Recalls by state

Recalls distributed in District of Columbia

FDA and USDA FSIS recalls whose distribution, as the agency recorded it, names District of Columbia: 6,372 records in 2,070 recalls, newest first.

More about these records

12,612 more were distributed nationwide and are on the food, medicine, device and pets and animals lists; CPSC and NHTSA do not record states.

Recent recalls

3 of 2,070

Nov. 4, 2026Class IFDA · Food

EDEN BROTHERS Broccoli Seeds…

Salmonella

Filed by: EDEN BROTHERS · Also listed under EDEN BROTHERS

Oct. 28, 2026Class IIFDA · Medical device

PNE Lead Implant Kit REF: 1701

Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Filed by: Axonics, Inc. · Also listed under Axonics

Oct. 28, 2026Class IIFDA · Medical device

Medtronic NDI Passive Spheres REF: 8801071… and 3 more products

Sterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to detect and track the spheres.

Filed by: Medtronic Navigation, Inc. · Also listed under Medtronic Navigation

More recalls

600 in all years

Oct. 28, 2026Philips Lumify Diagnostic Ultrasound SystemClass IUltrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which… Recall began Sept. 24, 2026
Oct. 21, 2026The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists…Class IIIn vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including… Recall began Aug. 18, 2026
Oct. 21, 2026DxU 840m Iris… and 1 more productClass IIThe rinse-line check valve has a shorter service lifespan than originally expected and requires annual replacement to prevent lamina fluid leakage… Recall began Aug. 12, 2026
Oct. 21, 2026Generic Name: FilmArray Pneumonia Panel Generic Name: FilmArray… and 2 more productsClass IIDue to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results Recall began Aug. 12, 2026
Oct. 14, 2026Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station…Class IIDue to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the… Recall began Sept. 8, 2026
Oct. 14, 2026Battle Bandage…Class IICompression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration… Recall began Sept. 2, 2026
Oct. 7, 2026Intrapulmonary Percussive Ventilation… and 6 more productsClass IILabeling updated warning not to use Intrapulmonary percussive ventilation (IPV) in conjunction with volatile anesthetic delivery systems because IPV… Recall began Aug. 18, 2026
Oct. 7, 2026HeartSine samaritan PAD (Public Access Defibrillator)…Class IIIProducts were distributed without the required Maintenance Supplement, which describes an extra check every 3 months in addition to the monthly check. Recall began July 27, 2026
Sept. 30, 2026ForeSight Elite Tissue Oximetry Cable REF HEMFSM10 UDI-DI code: 00690103210927 The non-invasive ForeSight…Class IIDue to incorrect switching of Channel 1 and 2 on the module and flag labels on the tissue oximetry cables. Recall began Aug. 11, 2026
Sept. 23, 2026REF:2B5LT Ethicon Endo-Surgery… and 5 more productsClass IIReusable access port system may crack or seperate during use. Recall began Aug. 19, 2026
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Sept. 23, 2026Brand Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Product Name: HEMOSPRAY ENDOSCOPIC HEMOSTAT Model/Catalog Number…Class IIDue to issue with endoscope adherence and inability to spray powder. Firm will provide an updated Instruction for Use (IFU). Recall began Aug. 20, 2026
Sept. 23, 2026Happiest Baby… and 1 more productClass IIExtra small (ES) and Extra-large (XL) infant sleep sacks have not been reviewed for safety and effectiveness by the FDA. Recall began Aug. 7, 2026
Sept. 23, 2026Plum administration sets and 7 more productsClass IIIntravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored… Recall began May 12, 2026
Sept. 23, 2026Philips Patient Information Center iX REF:866389 and 1 more productClass IIDue to software malfunction, patient information system may freeze and become unresponsive. Recall began July 31, 2026
Sept. 23, 2026BD Alaris Pump Infusion Sets 10561554* 10885403232565 50885403232563 BD Alaris Pump Infusion Set…Class IDue to discrepancies in specific attributes in the performance data for infusion sets, which may lead to inappropriate pump performance. Recall began Aug. 19, 2026
Sept. 23, 2026Power-Trialysis Short-Term Straight Dialysis Catheter… and 1 more productClass Ithis is a downstream recall of class I recall RES 98777 Recall began Aug. 10, 2026
Sept. 16, 2026HeartSine SAM 350P 350P US Device…Class IIDue to a damaged (over stretched) membrane tail that causes an intermittent fault. Recall began July 27, 2026
Sept. 2, 2026Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl… and 2 more productsClass IILabel does not declare walnuts in English
Sept. 2, 2026ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle… and 1 more productClass IIThe firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat… Recall began July 22, 2026
Aug. 26, 2026VITASIA ASIAN STYLE WOK SPICE MIX…Class ISalmonella. The firm received a positive test result of Salmonella in the product.
Aug. 26, 2026Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz and 3 more productsClass IIInaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated). Recall began July 15, 2026
Aug. 26, 2026Esteem Body Soft Convex Urostomy Pouch Model/Catalog Numbers: 423703…Class IIUrostomy Pouches may leak from cap during use. Recall began July 6, 2026
Aug. 26, 2026Paragonix Technologies Inc. KidneyVault Portable Renal Perfusion System REF# PRGNX-8008-001Class IIDue to a firmware defect, the portable organ transfer device datalogger may lose its configuration, resulting in a blank screen and loss of displayed… Recall began July 20, 2026
Aug. 26, 2026EndoFLIP System that includes: ENDOFLIP 1 SYSTEM EF-100 05391530810050 10884521809307 REFURBISHED SYSTEM…Class IIThe system's 24-hour usage limit results in catheters incorrectly flagged as expired, making them unavailable for clinical procedures. Recall began May 13, 2026
Aug. 19, 2026ERBECRYO 2 Cryosurgical Unit Model/Catalog Number: 10402-000Class IIA strong pull on the high-pressure transfer hose of cryosurgical unit may lead to pneumatic short circuit between he gas inlet and the connector… Recall began June 26, 2026
Aug. 12, 2026FilmArray NGDS Warrior Panel REF NGDS-ASY-0007 UDI-DI code: (01)00851458005136 The FilmArray NGDS Warrior…Class IIFirm has identified mismatches between the outbreak strain and the reference strain used in the development of its qualitative, multiplexed, nucleic…
Aug. 12, 2026Flow Anesthesia Machine Flow-i C20 6677200 Flow-i C30 6677300 Flow-i C40 6677400 Flow-i C20 6888520 Flow-i…Class IIEvents observed where anesthetic agent was not delivered when the vaporizer was activated. Failure to deliver the anesthetic agent may result in the… Recall began June 24, 2026
Aug. 12, 2026Brand Name: Quantum Rehab Product Name: Quantum 4Front 2… and 12 more productsClass IIIf the "Remind Me Later" option is selected for user reminders, reminder pop-up messages may appear while the wheelchair is in use. If this occurs… Recall began June 25, 2026
Aug. 5, 2026Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent…Class IDue to a Supercapacitor electrolyte leakage on Printed Circuit Board Assembly (PCBA) may damage the charger chip, causing fail-safe state and… Recall began June 25, 2026
July 29, 2026SnapshotGLO Wound Imaging Device…Class IIThe software controlling the wound imaging device's battery charging circuit was not designed to recognize and recover a battery that has fully…
July 22, 2026functional formularies LIQUID HOPE ORGANIC WHOLE FOODS MEAL… and 1 more productClass IISubpotent for Vitamin A. The firm discovered that the testing laboratory used the wrong method when testing for Vitamin A. The test results gave a… Recall began May 26, 2026
July 15, 2026Brand Name: Fletcher CT/MR Shielded Applicator Set Product Name… and 2 more productsClass IIDue to safety concerns regarding the detachment of the tip of the intrauterine tube (IU tube) that may remain within a patient. Recall began April 3, 2026
July 15, 20265008X Blood Tubing Set…Class IIPotential for Online Port Errors due to connection issues when connecting the SafeLine of the 5008X CAREset to the substitution fluid port of the… Recall began May 11, 2026
July 15, 2026Intracept Access Instruments…Class IIIntraosseous nerve ablation system instruments may have sterile barrier breach of the outer tray seal, which may introduce a risk of sterility… Recall began April 22, 2026
July 8, 2026GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States…Class IIDue to catheter separation Recall began May 19, 2026
July 8, 2026OTP5000 THORA/PARA TRAY… and 13 more productsClass IIDue to lidocaine ampoules being manufactured under deficient manufacturing practices by manufacturer, lidocaine ampoules are currently being recalled… Recall began May 21, 2026
July 8, 2026Covidien Shiley Disposable Decannulation Plug REF DDCP UDI-DI code: 10884522004060 Product Codes that include…Class IIDue to product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP. Recall began April 23, 2026
July 1, 2026INZONE DETACHMENT SYSTEM…Class IIEmbolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint… Recall began April 6, 2026
June 24, 2026Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular… and 2 more productsClass IIDue to 11 volt Backup Battery failures. Recall began May 13, 2026
June 24, 2026BD Connecta" BD Luer-Lok" 360 REF 394910 UDI-DI code: 00382903949106 BD Connecta" Stopcocks are used to…Class IIDue to stopcock issues when using the plastic luer-lok syringe, the connection at the Port C may over thread or continue to spin rather than… Recall began May 21, 2026
June 24, 2026iLet Bionic Pancreas…Class IIThe reason for the recall is: it was found in version 3.3.6 of the iLet ACE Pump firmware and all previous releases that a screen unlock failure… Recall began Sept. 23, 2025
June 24, 2026Mito Red Light…Class IIThe near-infrared therapy device contains a lithium-ion battery that may malfunction, causing it to catch fire or burst into flames. Recall began Feb. 12, 2025
June 24, 2026PARACENTESIS KIT… and 34 more productsClass ILidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have… Recall began April 21, 2026
June 17, 2026Individual Unit Label (both lid and front of cup): Whole Foods Market Kitchens Minestrone Soup…Class IContains undeclared allergen (shrimp).
June 17, 2026Merlin" Patient Care System (PCS) software Merlin" PCS 3650 programmer Model 3330 softwareClass IISoftware malfunction may occur during pacing capture threshold test of pacemaker resulting in programmer not successfully communicating the command… Recall began May 12, 2026
June 17, 2026Brand Name: CGuard Prime Carotid Stent System… and 5 more productsClass IIStent delivery system may encounter complications during deployment which may result in high resistance or inability to deploy the stent. Recall began May 1, 2026
June 10, 2026Brand Name: Da Vinci 5 Product Name: ASSY,DV5 TOWER,IS5000 Model/Catalog Number: 380746 Software Version: N/A…Class IIDue to unintentionally activated near infrared handheld camera when attempting to turn off illumination during normal clinical workflow transitions… Recall began April 24, 2026
May 27, 2026Swan-Ganz Catheter… and 2 more productsClass IICatheters may, due to a manufacturing process and material changes, leak/break from the (blue) proximal injectate lumen hub, which may lead to… Recall began April 8, 2026
May 20, 2026Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product… and 2 more productsClass IIA software defect in which a low-priority file I/O check blocks the higher-priority thread responsible for processing estimated glucose values (EGVs)… Recall began April 14, 2026
May 20, 2026Diowave Laser System…Class IISoftware update is needed for laser systems, for topical infrared heating to provide temporary relief of minor muscle and joint pain, spasms… Recall began Jan. 9, 2026
May 13, 2026french broad CHOCOLATE bette's bake sale (a multi-flavor bonbon assortment)…Class IUndeclared nut allergen (walnut) due to mislabeling. The product's printed tasting guide incorrectly identifies the Walnut Fudge and Peach Cobbler…
May 13, 2026ERBEFLO CleverCap CO2: Hybrid CO2 Tubing/Cap Set for Olympus Scopes &… and 2 more productsClass IIDevices providing sterile water/CO2/air to endoscopes were manufactured with a distal irrigation segment connector configuration that may be more… Recall began March 31, 2026
May 13, 2026Brand Name: Da Vinci X and Da Vinci Xi Product Name: da Vinci X…Class IIDue to manipulator containing screws with in the arm sub-assembly that my be susceptible to breaking. Recall began April 2, 2026
May 13, 2026Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06Class IReloads for curved-tipped stapler may potentially produce an incomplete staple line. Recall began March 11, 2026
May 6, 2026Brand Name: Leksell Vantage Arc System REF: 1053958Class IILocking mechanisms may not properly secure to the Arc system, resulting in shifting of coordinates during procedures. Recall began March 19, 2026
May 6, 2026Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog…Class IIDue to complaints of device breakage at the traction force gauge to handle joint. Recall began March 9, 2026
April 29, 2026nanOss 3D Advanced Bone Graft Substitute nanOss 3D Plus Advanced Bone Graft Substitute 90-300-251008: nanOss…Class IIProducts were incorrectly labeled with a 5-year shelf life. The approved and validated shelf life is four years. Recall began March 9, 2026
April 22, 2026Cytal Wound Matrix 2-Layer 5x5 cm… and 4 more productsClass IIIncreased rate of out-of-specification endotoxin results. Recall began March 19, 2026
April 22, 2026Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only…Class IIDue to increased in complaints their is the potential for endoscopic clipping device to malfunction. Recall began March 3, 2026
April 22, 2026iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareClass IIit was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI)… Recall began Aug. 13, 2025
April 15, 2026Stryker Sustainability Solution Color Cuff 24" (Yellow) Quick Connect Dual Port Single Bladder REF…Class IIDue to potential for tourniquet cuffs to detach from the bladder at the welding connection and result in the cuff not being able to maintain pressure. Recall began March 12, 2026
April 8, 2026" Dumpling Vegetable 4.5 oz 011110658067 " Loaded Dumpling Vegetable… and 1 more productClass IIForeign Object (Glass) Recall began March 5, 2026
April 8, 2026MiniMed 670G Insulin Pump (MMT-1760… and 13 more productsClass IIAll Medtronic MiniMed infusion pumps (Paradigm series, 600 series, and BLE 700 series) were found to be affected by unintended over- and… Recall began Feb. 13, 2026
April 1, 2026Favorina Chocolate Ladybugs German-Style Nougat…Class IILabel does not specify type of tree nut contained in the product.
April 1, 2026BD Alaris" System with Guardrails" Suite MX with Point of Care UnitClass IIDue to product labeling not indicating which Transport Layer Security (TLS) version that must be enabled on hospital network to ensure secure Wi-Fi… Recall began Feb. 11, 2026
April 1, 2026MiniMed" 780G…Class IIThree software defects (Pump Error 53, BG check, and Critical Pump Error (Open Book Image)) that occurred as a result of software updates (versions… Recall began Jan. 30, 2026
April 1, 2026CentrosFLO Hemodialysis Catheters… and 4 more productsClass I16F dual-valved splittable sheath introducer due to a design defect, may not split as intended, which may result in hemorrhage, foreign bodies… Recall began Feb. 13, 2026
March 25, 2026Battery Charging Station…Class IIIThe Battery Charging Station is an optional dual-bay charger used to charge the Cardiosave IABP Lithium- Ion batteries when they are not being used… Recall began Feb. 6, 2026
March 23, 2026FSIS Issues Public Health Alert for Ground Beef Products Due to Possible Foreign Material ContaminationProduct Contamination
March 11, 2026Gelsoft Plus…Class IIGelatin sealed woven polyester prostheses devices, designed for vascular repair, were incorrectly labeled with an additional month of shelf life.… Recall began Dec. 18, 2025
March 4, 2026MRI LED Mobile Exam Light Battery REF SL-111 This non-magnetic UL and CE approved battery is used in…Class IIDue to battery component overheating while charging resulting in melting of internal components and causing smoke. Recall began Oct. 13, 2025
March 4, 2026Brand Name: Hitachi Proton Beam Therapy System Ref: PROBEAT-FR and 1 more productClass IISoftware anomaly in the patient positioning system may result in positional discrepancy.
Feb. 25, 2026MOLLI 2 System System includes: MM1000 (Pack of 10)…Class IIDue to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized surgical tools dislodging markers using during… Recall began Jan. 21, 2026
Feb. 25, 2026MONARCH Platform…Class IIDevice for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to… Recall began Jan. 21, 2026
Feb. 25, 2026Broviac 4.2 Fr Single-Lumen CV Catheter Cutdown Tray with SureCuff Tissue Ingrowth Cuff Cat 60060Class IIDue to damage to outer tray that can potentially compromise the sterile barrier Recall began Dec. 12, 2025
Feb. 18, 2026da Vinci 5 Surgeon Console Viewer Display…Class IIRobotic-assisted surgical system has Viewer Display manufactured with outdated firmware, may result in loss of one display-loss of 3D surgical field… Recall began Dec. 30, 2025
Feb. 11, 2026Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome… and 29 more productsClass IIDevices which did not undergo thermoforming could deform and lose performance. Recall began Jan. 7, 2026
Feb. 11, 2026COULTER DxH Diluent…Class IIDue to specific lots of diluents contributing to elevated platelet Daily Checks background counts cycle with use with analyzers. Recall began Nov. 10, 2025
Feb. 4, 2026Brand Name: LimFlow Vector Product Name: LimFlow Vector Model/Catalog Number: VT-US-23Class IIIncorrect expiration date Recall began Dec. 5, 2025
Jan. 28, 2026SQ40S Blood Transfusion FilterClass IIDue to products being released for distribution prior to completion of the required quality control release process the sterility assurance cannot be… Recall began Nov. 3, 2025
Jan. 28, 2026The LDL-Cholesterol assay is comprised of two distinct phases…Class IIBeckman Coulter identified that LDL Cholesterol OSR6x96 is not meeting the performance claim listed in the Instructions for Use (IFU). LDL… Recall began Dec. 8, 2025
Jan. 28, 2026Brand Name: Ion Endoluminal System Product Name: Ion Vision Probe Bag Model/Catalog Number: 490127 Software…Class IIDue to probe bags that may have a compromised or incomplete sterile pouch seal. Recall began Dec. 4, 2025
Jan. 28, 2026Merit Medical Inflation Device.basixCOMPAK.30 atm/bar.20 mL Reference… and 6 more productsClass IIInflation device handle may detach from the syringe during procedure. Recall began Dec. 4, 2025
Jan. 28, 2026Tego Connector: REF: 011-D1000…Class IINeedle free access device intended as accessory to vascular access used in hemodialysis or accessory to intravascular administration sets has a… Recall began Dec. 19, 2025
Jan. 21, 2026CentriMag Blood Pump…Class IIAcute circulatory support system pump may not fit into the motor and reports received of the pump not being securely locked into the motor using the… Recall began Oct. 10, 2025
Jan. 21, 2026Detachable 10in Pend FRU-1 Pend component for the AIRO Computed… and 1 more productClass IIAIRO pendant replacement kits and upgrade do not possess the "Safe Hand Position Warning" label. Recall began Dec. 4, 2025
Jan. 14, 2026Codman Microsensor Basic Kit… and 1 more productClass IIPotential corrosion stains on the surface of the 14-gauge Tuohy Needle that is included in the Microsensor and Cerelink ICP Kits. Recall began Dec. 12, 2025
Jan. 14, 2026BD Pyxis ES Enterprise Server Catalog Numbers 1115-00…Class IIDue a software issue that may result in equipment not receiving timely updates of patient, medication, or related information from enterprise systems. Recall began Dec. 3, 2025
Jan. 7, 2026Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF…Class IIRetroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. Recall began July 14, 2022
Dec. 31, 2025Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in…Class IProduct may be contaminated with Listeria monocytogenes. Recall began Nov. 22, 2025
Dec. 31, 2025BECKMAN COULTER BICARBONATE REF: OSR6137 OSR6237 OSR6637 OSR6x37 Bicarbonate is a system reagent for the…Class IIBicarbonate reagent may generate falsely high Bicarbonate results due to interference with Lactate Dehydrogenase (LDH) in the test sample. Recall began Oct. 14, 2025
Dec. 31, 2025BD Pyxis MedStation ES…Class IIAutomated Dispensing Cabinets (ADC) received a Half Height CUBIE drawer firmware update, which caused a Cubie Insert event which prompts software to… Recall began Nov. 20, 2025
Dec. 24, 2025Alinity ci-series System Control Module (SCM)…Class IIAbbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the… Recall began Nov. 13, 2025
Dec. 24, 2025Brand Name: AART Silicone Carving Implant Product Name: Silicone… and 5 more productsClass IIDue to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket… Recall began Sept. 26, 2025
Dec. 10, 2025Costco Item# 19927 Kirkland Signature Caesar Salad… and 1 more productClass IIThe 3oz. sealed packet of Caesar Dressing in Costco Caesar Salad may contain plastic material. Recall began Nov. 7, 2025
Dec. 10, 2025Organic Moringa Leaf Powder (Moringa Powder)…Class IProduct tested positive for Salmonella. Recall began Nov. 4, 2025
Dec. 10, 2025Lumify Diagnostic Ultrasound System models : 795005…Class IIUltrasound system compatibility issues with Apple devices running iOS 18 may cause a failure to perform live imagining. Recall began Oct. 31, 2025
Dec. 3, 2025Option"ELITE Vena Cava Filter System REF 352506070E UDI-DI code: 00886333217151 The Option"ELITE Filter is…Class IIDue to complaints of increased resistance when advancing the dilator within the introducer sheath. This issue could potential result in procedural… Recall began Sept. 12, 2025
Dec. 3, 2025CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K…Class IIXXX Recall began Sept. 15, 2025
Nov. 26, 2025MONARCH Bronchoscope…Class IIPotential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible… Recall began Oct. 18, 2025
Nov. 26, 2025REF: CC286297 or BS737162 Automated Digital Cell Morphology analyzer DI-60…Class IIAutomated cell-locating device barcode reader may read the barcode of the previously processed slide resulting in a misattribution of diagnostic… Recall began Oct. 8, 2025
Nov. 26, 2025OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor FOBT…Class IIIA labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the… Recall began Oct. 6, 2025
Nov. 26, 2025PhD Hemostasis Valve…Class IIHemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in… Recall began Aug. 4, 2025
Nov. 26, 2025Brand Name: HeartMate Product Name: HeartMate 3 Left Ventricular… and 3 more productsClass IIDue to potential corrosion issues associated with the Backup Battery cable connector that may cause a Backup Battery Fault Alarm. Recall began Oct. 9, 2025
Nov. 19, 2025CEREPAK Detachable Coil System…Class IDetachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional… Recall began Oct. 2, 2025
Nov. 12, 2025Tandem Mobi Insulin Pump: Description/Catalog: Tandem insulin pumps are battery-operated infusion pumps…Class IInsulin pump includes a vibration motor that gives tactile feedback for any alerts, alarms, or malfunctions. Pump may exhibit false vibration motor… Recall began Oct. 6, 2025
Nov. 5, 2025Fusia Asian Inspirations brand Veggie Spring Rolls…Class IUndeclared shrimp
Nov. 5, 2025Assay: IMMULITE 2000 Intact PTH…Class IIThe potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal… Recall began Sept. 22, 2025
Nov. 5, 2025SuRgical Planner (SRP)… and 6 more productsClass IIA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any… Recall began Sept. 16, 2025
Nov. 5, 2025Magseed Pro 7 cm soft tissue marker… and 1 more productClass IIPotential for contamination with cotton fibers. Recall began Oct. 1, 2025
Nov. 5, 2025Brand Name: Alcon Laboratories… and 4 more productsClass IIDue to incomplete seals in the pouch which provide the sterile barrier. Recall began Aug. 5, 2025
Oct. 29, 2025Wegmans Large Ultimate Plain Cheesecake… and 5 more productsClass IContains undeclared pecans Recall began Sept. 26, 2025
Oct. 29, 2025Salem Sump PVC Tubes: Product Code/Product Name: 8888264911E ENFit"… and 5 more productsClass IIFirm has received complaints regarding Anti-Reflux Valve (ARV) breakage due to excessive force during use. Firm is providing additional guidance for… Recall began Sept. 18, 2025
Oct. 22, 2025Zenith Alpha 2 Thoracic Endovascular Graft…Class IAffected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular… Recall began Sept. 18, 2025
Oct. 15, 2025Harris Teeter ASIAGO TEXAS TOAST… and 1 more productClass IUndeclared Milk. During production the firm discovered that the ingredients "cheese and butter" is not listed in the ingredient statement and… Recall began Sept. 11, 2025
Oct. 15, 2025CorNeat EverPatch… and 1 more productClass IIReviewed complaints have identified that conjunctival wound dehiscence may result in early exposure of the surgical patch. Recall began Aug. 18, 2025
Oct. 8, 2025GORE ACUSEAL Vascular Graft…Class IIReports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to… Recall began Aug. 26, 2025
Oct. 1, 2025GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS… and 1 more productClass IUndeclared allergens (milk).
Oct. 1, 2025FilmArray NGDS Warrior Panel NGDS-ASY-0007 is a qualitative…Class IIFilmArray NGDS Warrior Panel (NGDS-ASY-0007) has an increased risk of internal control failures when testing positive blood culture, which may lead… Recall began July 10, 2025
Sept. 24, 2025Endico brand MIXED VEGETABLES… and 1 more productClass IProduct may be contaminated with Listeria monocytogenes.
Sept. 24, 2025NEUHAUS brand ORIGINAL BELGIAN CHOCOLATE…Class IProduct contains undeclared wheat. Recall began Aug. 4, 2025
Sept. 24, 2025Vercise Deep Brain Stimulation Systems Surgical Implant Manual…Class IIWire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire… Recall began July 8, 2025
Sept. 24, 2025Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC… and 2 more productsClass IDue to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device… Recall began Aug. 12, 2025
Sept. 17, 2025Wegmans Medium Camembert Soft Ripened Cheese… and 3 more productsClass IProducts may be contaminated with Listeria monocytogenes Recall began Aug. 12, 2025
Sept. 10, 2025Interventional Fluoroscopic X-Ray System…Class IIPotential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. Recall began Aug. 1, 2025
Sept. 10, 2025Superion IDS Kit Superion Indirect Decompression System 8MM…Class IIAs a result of a comprehensive product performance review it was determine that the device and instruments are not consistently meeting expected… Recall began June 6, 2025
Sept. 3, 2025BD Pyxis Product Name / UDI-DI code / Catalog No…Class IIAntivirus software was not consistently installed on impacted devices during the implementation process. Recall began May 8, 2025
Sept. 3, 2025BD PhaSeal Injector Luer (N30C)…Class IIClosed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a… Recall began June 16, 2025
Sept. 3, 2025Orascoptic Superior Visualization Custom loupes with Dragonfly frames and 5 more productsClass IIDue to complaints, loupe nose pads containing nickel may cause an allergic reaction. Recall began July 3, 2025
Aug. 27, 2025Burr Hole Cover Kit…Class IIResistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of… Recall began July 8, 2025
Aug. 27, 2025Pentax Medical Video Processor…Class IIDuring endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become… Recall began July 16, 2025
Aug. 20, 2025Description/REF: BD PYXIS MEDBANK MINI 1FH-1FM/169-137…Class IIIReports of delayed access to medication in automated dispensing cabinets because of the override/Add Item workflow. Recall began July 10, 2025
Aug. 20, 2025DreamStation Auto CPAP… and 2 more productsClass IDevices may possess a programming error resulting in an incorrect device configuration. Recall began June 30, 2025
Aug. 13, 2025Favorite Day Bakery Frosted Sugar Cookies…Class IIForeign Material (wood)
Aug. 13, 2025UIBC (Unsaturated Iron Binding Capacity)…Class IIBeckman Coulter identified that the Unsaturated Iron Binding Capacity (UIBC) assay is not meeting their labeled hemoglobin interference claims of no… Recall began June 26, 2025
Aug. 13, 2025BD Alaris Pump Module Model… and 1 more productClass IInfusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy… Recall began July 8, 2025
Aug. 6, 2025Volcano Visions Digital IVUS Catheter: PV.014P (Platinum)…Class IIReports of IVUS catheter and guide wire entanglement during radial-to-peripheral procedures, due to catheter use without appropriate sheath and/or… Recall began June 13, 2025
Aug. 6, 2025HeartSine SAM 350P…Class IIDue to a component manufacturing issue, Automated External Defibrillator may not function properly (deliver shocks) Recall began June 30, 2025
July 30, 2025Ritz Peanut Butter Cracker Sandwiches… and 3 more productsClass IIUndeclared allergens (Peanut) due to mispackaging
July 30, 2025Stryker… and 1 more productClass IIDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. Recall began June 18, 2025
July 30, 2025Covidien Nellcor Bedside SpO2 Patient Monitoring System: REF: PM100N…Class IIBedside SpO2 Patient Monitoring System alarms not heard/recognized, resulting in: treatment delay, lack of low oxygen saturation response… Recall began June 23, 2025
July 30, 2025HSG Procedure Tray… and 2 more productsClass IIThe HSG Procedure Trays and Endosee System Convenience Kits contain non-sterile iodine pouches, however the peel away lid labels incorrectly identify… Recall began June 11, 2025
July 30, 2025Azurion 7 M20…Class IIPotential for bolts connecting the gearbox to the mounting flange of the C-arm to become loose. Recall began June 4, 2025
July 23, 2025Kilwin's Mocha Truffle bulk 2.5lbs Kilwin's Mocha Truffles 4.75oz… and 2 more productsClass Iundeclared pecans Recall began May 27, 2025
July 16, 2025Wegmans Semi-Sweet Chocolate Nonpareils…Class IIUndeclared milk Recall began June 16, 2025
July 16, 20251. USA APLS RED DEL TOTE 2… and 29 more productsClass IIMay be contaminated with fluid from a reach truck Recall began June 7, 2025
July 16, 2025Wegmans brand Mini Muffins… and 2 more productsClass IIProduct may contain foreign objects of metal origin. Recall began June 14, 2025
July 16, 2025Brand Name: Alcon Laboratories… and 2 more productsClass IIDue to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area… Recall began April 28, 2025
July 16, 2025Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial… and 5 more productsClass Idue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. Recall began May 14, 2025
July 9, 2025Peak Cocktails Blood Orange Spritz 8.4 fl oz aluminum cans sold as an individual flavor and in variety packs…Class IIOverpressurization leading to exploding cans Recall began June 3, 2025
July 9, 2025ZENSHI HANDCRAFTED SUSHI Arroz Picante Roll… and 82 more productsClass ISalmonella. The firm received cucumbers which were recalled due to possible Salmonella. The cucumbers were used to make Sushi. Recall began May 20, 2025
July 9, 2025REF: 335775 , BD FACS, 7-Color Setup Beads, 25 setups per kit, Rx… and 1 more productClass IIDue to customer complaints, errors in spectral overlap factors table for 7-color setup beads may affect accurate setup of the flow cytometry… Recall began June 3, 2025
July 2, 2025REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487…Class IIDue to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when… Recall began April 8, 2025
July 2, 2025Product Name [REF]: Supply Server…Class IIDuring automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then… Recall began May 8, 2025
July 2, 2025REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00… and 8 more productsClass IIDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Recall began May 21, 2025
June 25, 2025Optima Coil System REFs/UDI-DI codes: OPTI0156BLK 00810068568875… and 1 more productClass IIDue to radiopaque (RO) marker was not visible during angiography and it was determined that the RO marker was not manufactured to specification. Recall began May 8, 2025
June 18, 20253909520 2/5# IMPERIAL FRESH CUCUMBER DICED 3/8 SK-ON ALL LOT CODES… and 7 more productsClass ICucumbers have the potential to be contaminated with Salmonella
June 18, 2025Allon 2001…Class IIAn investigation into a report of the patient wrap (ThermoWrap), used with the Allon device, exceeding the set temperature determined that if: 1. The… Recall began May 13, 2025
June 11, 2025Giant…Class IIUndeclared Allergen (walnuts), was not on outer packaging but was on the inner packaging of product. Recall began April 4, 2025
June 11, 2025AMCE GREEK SALAD AUTHENTIC FS…Class ISalmonella. Greek Salad products were made with recalled cucumbers from Bedner Grower's Company which are contaminated with Salmonella and implicated…
June 11, 2025GNC Women's 30+ Vitapak…Class IIIUndeclared Fish allergen (parvalbumin). Recall began April 25, 2025
June 11, 2025Sample probe sucks a sample dispensed into a tube or cup and… and 1 more productClass IIA manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent… Recall began April 30, 2025
June 4, 2025Atellica IM Homocysteine Calibrator (2 Pack)… and 1 more productClass IICertain lots of Atellica IM Homocysteine Calibrator and ADVIA Centaur HCY Calibrator do not meet the assay Instructions for Use (IFU) reference… Recall began April 15, 2025
May 28, 2025Bard Minnesota Four Lumen Esophagogastric Tamponade Tube… and 4 more productsClass IDue to customer complaints, there is a potential for users to be unable to or find it difficult to remove the plastic plugs in order to inflate the… Recall began April 17, 2025
May 14, 2025Philips Tempus Pro Patient Monitor…Class IIPatient Monitor software update to address issues:1)May freeze at startup with MPM Application error and Attention Restart Required…
May 7, 20253.0 Liter Disposable Set (4 sets/case)…Class IIPotential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during… Recall began March 31, 2025
May 7, 2025Hyperthermia Pump Procedure Kit… and 2 more productsClass IIPotential crack in the female connector located on the Heat Exchanger in the set, which will lead to a fluid leak through the crack during priming of… Recall began March 31, 2025
April 30, 2025Radiometer ABL90 Series…Class IIABL90 FLEX and ABL90 FLEX PLUS analyzers running with Radiometer Windows 10 versions RWIN10 1.0 and RWIN10 1.1 may unexpectedly freeze (the analyzer… Recall began March 21, 2025
April 30, 2025Merit Medical… and 1 more productClass IIUpdate to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners. Recall began March 14, 2025
April 30, 2025BD PYXIS MEDBANK (Name…Class IIUsers trying to restock a single bin location of an automated dispensing cabinet, during pocket exchange restocking workflow, may experience a… Recall began March 11, 2025
April 30, 2025NIM Vital Nerve Monitoring System: CONSOLE NIM4CM01 NIM 4.0…Class IINerve Monitoring System with certain software versions has potential for increased stimulus artifact, which may require troubleshooting, and may lead… Recall began March 10, 2025
April 23, 2025Trader Joe's Hot Honey Mustard Dressing (SKU #80152)…Class IUndeclared peanuts, soy, sesame, and wheat.
April 23, 2025Maquet VH-3010 Power Supply…Class IIIncorrect resistor utilized in the VH-3010 Power Supply, which may cause the jaws of the HemoPro 2 to not adequately heat up. Recall began March 10, 2025
April 23, 2025HeartMate Mobile Power Unit: REF: 107754…Class ILeft Ventricular Assist System Mobile Power Unit (MPU) may have electrical component that may cause MPU not to turn on, unprompted shut down, or… Recall began March 13, 2025
April 23, 2025BD 4 Fr Single-Lumen PowerPICC Catheters…Class ICatheters indicated for short-or-long term access to the central venous system have tubing that exceeded melt flow index specification (higher)… Recall began March 11, 2025
April 16, 2025BD Pyxis" MedBank" Mini and BD Pyxis" MedBank" Tower…Class IIDue to a software bug, automated dispensing cabinet is unable to calculate countback discrepancies during the issue process, which causes incorrect… Recall began March 11, 2025
April 9, 2025Brand Name: QIAstat-Dx Product Name: QIAstat-Dx Respiratory Panel Plus Reference Number (REF): 691224…Class IIIdentified faulty cartridges. If such a faulty cartridge is used for sample testing, false test results could occur.
March 26, 2025Savage Cat Food Chicken 84 oz…Class IHighly Pathogenic Avian Influenza (HPAI) contamination in raw cat food.
March 26, 2025Madras Curry Powder sold in 3 different package sizes…Class IIElevated levels of lead 5.48mg/kg and 2.59mg/kg in (2) lots of Madras Curry Powder. Recall began Jan. 28, 2025
March 26, 2025IsoLoc Short Profile Prostate Immobilization Treatment Balloon Device Kit…Class IIProduct is mislabeled with the incorrect fill volume. Recall began Feb. 4, 2025
March 26, 2025Microstream Instructions for Use and Part Number used with… and 9 more productsClass IINeonatal-Infant and Adult-Pediatric CO2 Sampling Line/Airway Adapter/CO2 Oral-Nasal Filter Line/Intubated Filter (CO2) Line device users may… Recall began Feb. 17, 2025
March 26, 2025BD Pyxis: Anesthesia Station ES…Class IISync timeout may occur between the server and automated dispensing device, due to a server software error which may occur if syncing a large amount… Recall began Feb. 6, 2025
March 19, 2025Ulker Kekstra Mini strawberry… and 5 more productsClass IMilk not declared as the major food allergen source for the ingredient Whey Recall began Feb. 15, 2025
March 19, 2025Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump…Class IITheir is a potential of fluid leakage from the centrifugal blood pump pump during the priming procedure or during clinical procedures. Recall began Jan. 16, 2025
March 19, 2025BD Alaris Systems Manager… and 1 more productClass ISoftware issue that may result in outdated automated programming request(APR) being sent to the progressive care unit (PCU).
March 12, 2025Noble Made Garlic Parmesan Wing Sauce…Class IICustomer complaints of bottles foaming when opened
March 12, 2025AURORA Surgiscope System…Class IIPossibility for the obturator to break (separate). Recall began Feb. 6, 2025
March 12, 2025Paradigm REF: MMT-712 and MMT-715 and 11 more productsClass IIAll Medtronic MiniMed pumps (Paradigm series, Minimed 530G, 6XX series, and 7XX series) were found to have the potential for abnormal insulin… Recall began Jan. 31, 2025
March 12, 2025Medtronic Pipeline Vantage Embolization Device with Shield Technology… and 1 more productClass IUse of embolization device with diameters greater-than-or-equal-to 4mm may lead to incomplete wall apposition and/or braid deformation… Recall began Jan. 30, 2025
March 5, 2025BD Alaris Pump Module REF 8100 The BD Alaris System with Guardrails Suite MX is a modular infusion pump and…Class IIDue to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This… Recall began Jan. 23, 2025
March 5, 2025138913-01 BD PYXIS MEDBANK MINI CR-2HH-1FH-P 169-114 BD PYXIS MEDBANK… and 3 more productsClass IILabeling update to include a contraindication statement against the use of medicine cabinets in procedure and operating rooms. Recall began Jan. 8, 2025
March 5, 2025BD Pyxis MedFlex 2.0 REF 1139-00 Bio-ID Spare Parts REF 353200-01 The BD Pyxis" MedFlex is an Automated…Class IIDue to fingerprint scanner failing resulting in the scanner heating up. Recall began Jan. 23, 2025
March 5, 2025BD Pyxis: MedFlex…Class IIAutomated dispensing device labeling is being updated to strengthen labeling around manual access to medications to address the risk of potential… Recall began Jan. 10, 2025
Feb. 26, 20253M Prevena Plus 125 Therapy Unit and System Kits REF: PRE3021US… and 1 more productClass IIDue to increase in complaints related to leak alarms Recall began Jan. 17, 2025
Feb. 19, 2025Biological…Class IISpore test strip monitoring system, designed for routine monitoring of sterilization processes, may have a printing error on the return envelope that… Recall began Dec. 11, 2024
Feb. 19, 2025Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DC… and 1 more productClass IDue to faulty circuit board in speed control remote use in conjunction with a wheelchair power assist, their is a potential for lost of control of… Recall began Dec. 20, 2024
Feb. 12, 2025UNiD" Adaptive Spine Intelligence UNiD Spine Analyzer Product Number SW3002 UDI-DI code 03613720286929 Two…Class IIDue to software anomalies that may impact on rod planning specifically, certain optional surgical parameters may have had errors that resulted i… Recall began Dec. 3, 2024
Feb. 12, 2025Temporary Titanium AbutmentsClass IICertain definitive dental implant restoration cases may have included a temporary titanium abutment (cylinder), rather than a definitive titanium… Recall began Dec. 6, 2024
Feb. 5, 2025BD Pyxis MedStation ES AUX Tower REF 343 BD Pyxis " MedStation 4000 AUX Tower REF 314 The BD Pyxis"…Class IIDue to an increase in complaints of door latch assembly failures that may cause the doors to be left in an open state potentially causing inventory… Recall began Feb. 14, 2023
Feb. 5, 2025Medtronic PIN…Class IIDue to an increase in complaint that the percutaneous reference pin would not fit into the patient reference frame or percutaneous pin adapter. Recall began Dec. 4, 2024
Jan. 29, 2025Buttered Vegetables KEEP FROZEN…Class IIUndeclared Milk. During an FDA investigation the manufacturer was notified that the label does not list the allergen milk in the ingredient statement. Recall began Dec. 20, 2024
Jan. 29, 2025BD PCR Cartridges used with MAX System…Class IIPotential for signal drift in specific lots of BD PCR Cartridges. Recall began Dec. 19, 2024
Jan. 29, 2025CODMAN CERTAS Plus Programmable Valve Inline Small Valve Only… and 2 more productsClass IIPotential for certain SKUs and lot numbers were distributed with the incorrect product description on the internal and external labels. Recall began Dec. 16, 2024
Jan. 27, 2025FSIS Issues Public Health Alert for Wegmans Frozen Fully Cooked Chicken Nuggets Due to Possible Extraneous…Product Contamination
Jan. 22, 20258MM, Tenaculum Forceps REF 470207 Instrument used with the da Vinci… and 1 more productClass IIDue to an increase in complaints for pitch cable failures related to forceps and small Graptor instruments Recall began Dec. 19, 2024
Jan. 22, 20258MM, MONOPOLAR CURVED SCISSORS, IS4000 REF 470179 and 36 more productsClass IIDue to increased complaints regarding frayed or broken grip cables on reusable instruments with jaws. Recall began Dec. 19, 2024
Jan. 8, 20253M Unitek Transbond Plus Self-Etching Primer REF 712-090 (100 unit box) 712-091 (20 unit box) Transbond Plus…Class IIDue to an increase of complaints for bracket bond failures and skin irritation or blistering. Recall began Nov. 26, 2024
Jan. 1, 2025ZOE brand Daily 30+ Prebiotic blend…Class IIProduct may contain foreign objects: small metal pieces and/or stones
Jan. 1, 2025The Merlin PCS 3650 programmer Model 3330 The Merlin PCS programmer model 3650 is a portable…Class IIDue to a programmer software anomaly, during finalizing of the leadless pacemaker system, a specific sequence of programmer actions combined with a… Recall began Nov. 21, 2024
Jan. 1, 202520/30 INDEFLATOR… and 3 more productsClass IIInflation Device used during cardiovascular procedures may leak in the indeflator at the hose rotating luer or at the gauge, which could lead to air… Recall began Nov. 6, 2024
Dec. 25, 2024OEC 3D REF Image-Intensified Fluoroscopic X-Ray System… and 3 more productsClass IIDue to manufacturing issue of insufficient sealing of X-ray tubes and can result in a potential oil leak and loss of fluoroscopic imaging capability. Recall began Nov. 21, 2024
Dec. 25, 2024Turbo Elite Laser Atherectomy Catheter Model Number / UDI-DI code / Product Description 414-151 /…Class IIDue to complaints received for the marker band detaching from the distal tip of the catheter and remaining in the patient as laser catheter was… Recall began Nov. 25, 2024
Dec. 18, 2024BD Pyxis MedStation ES… and 2 more productsClass IIDue to a software issue, automated dispensing cabinet devices may open the wrong cubie pocket or position, which can lead to: 1) Unintended and… Recall began Nov. 14, 2024
Dec. 11, 2024Wegmans Large Asian Sesame Salad with Chicken and Asian Peanut DressingClass IContains undeclared egg Recall began Nov. 8, 2024
Dec. 4, 2024Atwater's Spider Web Tarts…Class IUndeclared tree nuts (almonds) Recall began Oct. 21, 2024
Dec. 4, 2024Curio Spice Co. brand Grains of Paradise (Korerima)…Class IIProduct may be contaminated with mold. Recall began Oct. 31, 2024
Dec. 4, 2024Merlin@home Transmitter REF EX1100 The Merlin@home" (M@h) transmitter… and 1 more productClass IIIDue to heart transmitter not being able to upgrade to the current software version in the field after experiencing a power interruption during a… Recall began Oct. 1, 2024
Dec. 4, 2024V.A.C. Ulta Therapy Unit REF CAPULTDEV01 & ULTDEV01 The 3M" V.A.C. Ulta Negative Pressure Wound Therapy…Class IIDue to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
Nov. 27, 2024OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers…Class IIBattery movement led to damage of one of the battery cells causing it to short to the battery retention bracket Recall began Oct. 15, 2024
Nov. 20, 2024Irrigation Tubing for KARL STORZ Endomat Select UP210 REF 031523-10 Tubing Set…Class IIDue to improper labeling of products. An intended use on the label has not been reviewed and approved by FDA for distribution in the U.S. Recall began Oct. 21, 2024
Nov. 13, 2024Hammond's Dark Chocolate Filled Mini Waffle Cones…Class IIUndeclared allergen: milk Recall began Aug. 30, 2024
Nov. 6, 20241) Flex Extenders…Class IIDue to connector within the circuit flex extender not meeting specifications resulting in a low connection force and as a result, the connector may… Recall began Sept. 27, 2024
Nov. 6, 2024Abbott Alinity m HPV AMP Kit… and 1 more productClass IIAbbott has identified an increase of incidences regarding Error Code (EC) 9198 (Positive control is non-reactive) while using the Alinity m HR HPV… Recall began Sept. 12, 2024
Oct. 30, 2024Quantimetrix Urine Chemistry Control Set Dipper Urinalysis Dipstick Testing Levels 1 & 2 6 X 15 mL-IVD…Class IIThe Quantimetrix Dipper Urinalysis Dipstick control was shipped without the validated summer packaging and may have been exposed to temperatures… Recall began Sept. 17, 2024
Oct. 23, 2024Grabeez The Big Cheese SNACK MIX…Class IIUndeclared Almonds & Cashews. The firm was notified by their customers that the product contains a trail mix instead of the cheese mix. The trail mix…
Oct. 23, 2024S'mores Bites…Class IUndeclared Allergen, milk - a mix-up between the product description and the ingredient list. Milk Chocolate was listed in the product description… Recall began Sept. 13, 2024
Oct. 23, 2024Blue Diamond Digital Inflation Device… and 9 more productsClass IIInflation devices may have a small hole in the sterile barrier of the device and use of affected devices may result in exposure to pathogens/pyrogens… Recall began Aug. 19, 2024
Oct. 16, 2024MEDIHONEY Dressing with Active Leptospermum Honey Wound and Burn Dressing W/APPLICATOR…Class IIThere is a potential for pinholes in the applicator pouch film which creates a sterility concern. Recall began Sept. 13, 2024
Oct. 16, 2024Monarch Platform (Endoscopy)… and 1 more productClass IIEndoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which… Recall began Aug. 2, 2024
Oct. 9, 2024DAILIES TOTAL1…Class IIMaterial with a quality issue was used in contact lens production, so contact lenses may not meet quality and/or performance standards for the… Recall began Aug. 8, 2024
Oct. 9, 2024MiniMed 630G Insulin Pump… and 2 more productsClass IInsulin pumps that have been dropped, bumped, or experienced physical impact may have damage to internal electrical components, which may cause… Recall began July 31, 2024
Oct. 2, 2024PT301US Airvo 3 Respiratory Support Device with software version 1.2.0 and/or 1.5.1 The Airvo 3 is intended…Class IIDue to a software issue, affected devices that are set up with High Pressure Oxygen (HPO), if the flow alignment alarm occurs, the device will… Recall began Aug. 7, 2024
Oct. 2, 2024Karl Storz… and 7 more productsClass IIVarious medical device product IFUs contain reprocessing modalities that have not been reviewed and/or approved for safety and efficacy by the FDA. Recall began July 23, 2024
Sept. 25, 2024Wegmans PECAN BLEND…Class IIUndeclared Almonds. The firm was notified by their customer that the product contains undeclared almonds. Recall began Aug. 23, 2024
Sept. 25, 2024HAWK Warming Grid… and 2 more productsClass IIIncorrect expiration date.
Sept. 25, 2024ViewPoint… and 1 more productClass IIThe National Institute of Standards and Technology (NIST) has identified in the National Vulnerability Database (NVD) that NexGen Healthcare Mirth… Recall began Aug. 8, 2024
Sept. 25, 2024Alaris System PC Unit Model 8015… and 4 more productsClass IIDue to affected devices that may have bent female IUI connector and may not be operable and potentially cause delays in the start of the infusion or… Recall began Aug. 15, 2024
Sept. 18, 2024American Outdoor Products…Class IIElevated levels of lead
Sept. 18, 2024BDAY CAKE MOCHI CRUNCH packed in pink plastic pouch packaging…Class IILabel has a Contains statement that is missing milk and coconut (tree nut) that are declared in the ingredients statement.
Sept. 18, 2024FILMARRAY 2.0 INSTRUMENT… and 1 more productClass IISome automated in vitro diagnostic modules and instruments manufactured or serviced between May 2022 and May 2024 were calibrated with internal… Recall began Aug. 7, 2024
Sept. 11, 2024Heparin… and 1 more productClass IIDue to packaging defects, sterility assurance and heparin activity may be compromised. Recall began July 1, 2024
Aug. 28, 2024Great Value…Class IIProduct contains inorganic arsenic above action level set in industry guidance (13.2ppb)
Aug. 28, 2024Covideien McGRATH MAC Video Laryngoscope…Class IIIFU update to address device's battery handling information. Recall began July 9, 2024
Aug. 28, 2024GM60A. Digital Diagnostic Mobile X-Ray SystemClass IIPotential for the anti-fall system of the device arm to fail. Recall began July 8, 2024
Aug. 28, 2024Ventana anti-CD10 (SP67) Rabbit Monoclonal Primary Antibody…Class IITheir is a potential for high background and off-target staining when using the monoclonal primary antibody which can result in false positive… Recall began June 27, 2024
Aug. 28, 2024McGrath Mac Video Laryngoscope… and 1 more productClass IBattery management system within Laryngoscope devices may deplete below the deign threshold which may result in thermal event followed by risk of… Recall began July 9, 2024
Aug. 28, 2024ClotTriever XL Catheter…Class IThrombectomy system catheter instructions for use updated to reduce adverse events due to the following circumstances: 1) Fibrous, firmly adherent… Recall began July 19, 2024
Aug. 21, 2024WAVEWRITER ALPHA: Model: SC-1216…Class IISpinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device… Recall began July 17, 2024
Aug. 21, 2024Cepheid…Class IISpecimen collection device may leak after the patient sample swabs have been inserted into the test tubes, which could result in biohazard exposure… Recall began June 20, 2024
Aug. 21, 2024HeartMate 3 System Controllers provided within the following HeartMate 3 Left Ventricular Assist System…Class IILeft ventricular assist system controller UI membrane/screen may lift along the edge of the controller housing, and if controller is exposed to… Recall began June 25, 2024
Aug. 21, 2024Various Merit Medical convenience kits that contain recalled Jiangsu… and 22 more productsClass IIMedical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality… Recall began June 11, 2024
Aug. 14, 2024CryoValve SG Pulmonary Human Heart Valve… and 1 more productClass IIGrafts were found to have been approved, released, shipped and implanted with an invalid test results. Recall began May 28, 2024
Aug. 14, 2024BIOFIRE FILMARRAY Gastrointestinal (GI) Panel REF RFIT-ASY-0116 (30 test kit) BIOFIRE FILMARRAY…Class IIDue to increase of false positive Vibrio/Vibrio Cholerae results when using a certain transport medium. Recall began May 16, 2024
Aug. 14, 2024Puritan Bennett 500 Series Ventilators (Description/REF): PURITAN BENNETT 560 VENTILATOR/4096600…Class IAny single affected ventilator should only be used for the 10- year labelled service life, but if longer ventilatory support is required using more… Recall began June 24, 2024
Aug. 7, 2024Diamond Shruumz Infused Cones Cookies and Cream… and 21 more productsClass IToxic levels of muscimol Recall began June 27, 2024
Aug. 7, 2024Arctic Sun Temperature Management Systems…Class IIIf temperature management system fails to reach correct target water temperature while device is operating in patient control mode, due to sudden… Recall began June 27, 2024
July 31, 2024Abbott Infinity 5… and 3 more productsClass IITheir is a potential that the implantable pulse generator replacement indicator and end of service date may be shorter than indicated in the product… Recall began May 22, 2024
July 31, 2024Beckman Coulter…Class IILIH Influence check settings for Lipemia are incorrect which may result patient samples being reported as false low results or cause a high result to… Recall began May 27, 2024
July 31, 2024ABL800 FLEX Model Numbers 393-800 and 393-801 The ABL800 FLEX analyzers are intended for: " In Vitro testing…Class IIIssue with analyzer when the pH of the calibration solution decreases during the in-use period potentially because of bacterial growth in the… Recall began May 31, 2024
July 24, 2024VACUETTE TUBE 8 ml CAT Serum Separator Clot Activator 16x100 red cap-yellow ring…Class IIThe firm received reports that some blood collection tubes have experienced issues with clotting and poor separation due to missing additive. The… Recall began May 14, 2024
July 24, 2024Abbott Proclaim XR 5 Implantable Pulse Generator… and 11 more productsClass IIThe duration between the implantable pulse generator reaching the elective replacement indicator threshold and end of service may be shorter than… Recall began May 16, 2024
July 24, 2024BD Multitest 6-Color TBNK CE-IVD…Class IIMultitest with compromised raw material used to assess immune system status may result in flow cytometry plot with unusual staining pattern… Recall began May 8, 2024
July 17, 2024AURORA Surgiscope System…Class IIPotential sheath damage that could lead to tissue damage and/or track hemorrhage. Recall began June 7, 2024
July 17, 2024Kosmos on iOS impacting iOS…Class IIUltrasound system has a bug in affected iOS software, which after DICOM export, can cause inaccuracy in postprocessed measurements done in 3rd party… Recall began May 9, 2024
July 10, 2024Italiamo brand Melanzane alla Parmigiana pregratinate (Eggplant Parmesan) 450g…Class IIUndeclared wheat and milk (foreign language labeling)
July 10, 2024Abbott Liberta RC…Class IIDeep brain stimulation system will first turn off after approximately 50 days after the system is activated and subsequently, this same action will… Recall began May 16, 2024
July 10, 2024BD Alaris System Manager REF: 9601…Class IIDue to a software issue the PC unit may not connect to the server which could impact wireless data transmission to and from the server. Recall began May 21, 2024
July 10, 2024BD Pyxis… and 1 more productClass IIMultiple socket-outlet power strips that shipped with automated dispensing cabinet devices have not been certified to International Electrotechnical… Recall began May 13, 2024
July 3, 2024Chef Select 2 Garlic Baguettes filled With Garlic Butter 2x175 g… and 1 more productClass IIUndeclared wheat and milk (foreign language labeling)
July 3, 2024Prelude Roadster Guide Sheath REF: -PG4F45S -PG4F90S -PG5F45MP -PG5F45R -PG5F45S -PG5F45S018 -PG5F90MP…Class IIDue to older version of Instruction for Use (IFU) instructing to ensure that the value and the sheath are tightly connected before use. This may… Recall began May 22, 2024
June 19, 2024EsoFLIP…Class IIDue to saline conductivity issues, their is a potential that dilation catheters may provide inaccurate esophageal diameter measurements that may lead… Recall began April 25, 2024
June 12, 2024Philips Tempus LS-Manual Defibrillator…Class IISimultaneous ECG measurements with multiple devices, including a manual defibrillator, on the same patient may cause electrical noise or… Recall began May 9, 2024
June 12, 2024Brand Name: GlideScope Core 15-inch Monitor Model/Catalog Number… and 1 more productClass IIDue to software issues, their is the potential for loss of image or a degradation of the image when using the monitor with other connectable devices. Recall began April 29, 2024
June 12, 2024The Synchro Neuro Guidewires are a steerable guidewire family with a… and 2 more productsClass IIStryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the… Recall began April 18, 2024
June 5, 2024BD Pyxis MedStation ES… and 5 more productsClass IIPotential fluid ingress of anesthesia station or med station may result in smoke, system downtime and/or fire. Recall began April 15, 2024
June 5, 2024Trevo XP ProVue Retriever 4 x 20… and 7 more productsClass IINeurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance… Recall began April 23, 2024
June 5, 2024Vercise Genus Deep Brain Stimulation (DBS) Implantable Pulse Generator IPG: R16 IPG KIT…Class IIDeep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) may experience routine system check during IPG charging, which may cause device reset.… Recall began April 18, 2024
May 29, 2024chuao CHOCOLATIER potato chip mini chocolate bar…Class IIIUndeclared hazelnut
May 29, 2024IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests)… and 1 more productClass IIThe potential for falsely elevated patient sample results when using impacted lots (782, 783, 785, 786, 787, 788, 789, 790, 791, 792 and 793), of… Recall began April 23, 2024
May 22, 2024Patient Information Center iX and Patient Information Center iX Expand…Class IIEvent Catalog information does not save when copied and transferred from one unit to another. Recall began April 19, 2024
May 22, 2024HeartSine samaritan PAD (Public Access Defibrillator)…Class IIAutomated external defibrillators have a manufacturing issue that could prevent the device from delivering instructional voice prompts to the user… Recall began April 8, 2024
May 8, 2024Abbott Aveir Leadless Pacemaker…Class IITheir is a potential that electromagnetic interference may cause leadless pacemaker may result in mode change. Recall began Feb. 5, 2024
May 8, 2024Keller Funnel 2…Class IITheir is a potential that breast implants lack the lubricious coating that allows them to slide through the funnels during the implantation procedure. Recall began March 14, 2024
May 8, 2024Thoratec HeartMate 3… and 1 more productClass IPotential for a leak path at the seal interface between the left ventricle assist system inflow cannula and the titanium apical cuff. Recall began March 1, 2024
May 1, 2024Masimo Rad-G Refurbished… and 1 more productClass IITheir is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. Recall began Feb. 15, 2024
May 1, 2024QUIDEL InflammaDry MMP-9 Test… and 1 more productClass IIThere are two windows on the test device, the control line window and the test results window. The line for the test results window were misaligned.… Recall began March 5, 2024
April 24, 2024Masimo Rad-G… and 3 more productsClass IITheir is a potential that Oximeter may automatically power off and on resulting in loss of monitoring. Recall began Feb. 15, 2024
April 24, 2024Tablo Hemodialysis System…Class IHemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may… Recall began March 6, 2024
April 17, 2024Deluxe brand Macarons Party Edition 35 pieces 455g (35 x 13g)…Class IIUndeclared Wheat, Soy, Egg, Milk, Tree Nuts (foreign language labeling)
April 17, 2024Egg salad sandwich packaged in clamshell for individual sale…Class IITuna salad sandwich was mislabeled as an egg salad sandwich. There is an undeclared allergen of fish (Tuna).
April 10, 2024Karl Storz SE & CO. KG… and 2 more productsClass IIInadequate reprocessing validation evidence Recall began Feb. 27, 2024
April 3, 2024Karl Storz SE & CO. KG…Class IISterility Assurance cannot be guaranteed for hand instruments. Recall began Feb. 27, 2024
April 3, 2024Nordic Naturals Baby s Vitamin D3 liquid…Class IIElevated levels of vitamin D3 Recall began Feb. 7, 2024
April 3, 2024Epix Universal Clip Applier… and 1 more productClass IITheir is the potential that Universal Clip applier may not load clip after the trigger is actuated. Recall began Jan. 30, 2024
April 3, 2024Medivance Neonatal ArcticGel Pads…Class IINeonatal pads are experiencing reduced water flow, which may reduce or prevent water heating or cooling performance of the pads that are part of a… Recall began Feb. 16, 2024
March 27, 2024HeartMate II Left Ventricular Assist System (LVAS): 1… and 1 more productClass IObserved outflow graft deformation known as Extrinsic Outflow Graft Obstruction (EOGO) associated with Left Ventricular Assist System. Recall began Feb. 19, 2024
March 20, 2024BrightFarms Southwest Chipotle Salad Kit Ready to eat salad kit containing green lettuce (grown by indoors at…Class IProduct ingredient may be contaminated with Listeria monocytogenes. Recall began Feb. 7, 2024
March 20, 2024Banana Pepper Rings 16 FL OZ (1PT) 473ml…Class IIIContainer integrity issued (punctured lid) Recall began Jan. 25, 2024
March 13, 2024Wegmans Harissa Hummus Topped With Harrisa 10.5 ounce (298 g)…Class IProduct contains undeclared sesame. Recall began Feb. 2, 2024
March 13, 2024Marketside Bacon Ranch Crunch Chopped Salad Kit 12.76oz… and 1 more productClass IProduct has the potential to be contaminated with Listeria monocytogenes. Recall began Feb. 7, 2024
March 13, 2024BD Pyxis: MedStation ES…Class IIAutomated dispensing cabinets, running affected software, and Windows 10 operating system may experience the application randomly hang, freeze and/or… Recall began Feb. 1, 2024
March 13, 2024MIC* Gastric-Jejunal Feeding Tube with ENFit Connectors: a) MIC*… and 1 more productClass IMIC* Gastric - Jejunal Feeding Tube Kits contain a sterile pre-filled syringe subsequently recalled by Nurse Assist. Recall began Jan. 16, 2024
March 6, 2024Medtronic Duet External Drainage and Monitoring System… and 4 more productsClass IPotential for catheter disconnection from the patient line stopcock connectors. Recall began Jan. 22, 2024
Feb. 28, 2024Philips Allura Xper Interventional Fluoroscopic X-ray Systems…Class IIDual In-Line Memory Modules (DIMMs) may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of… Recall began Jan. 2, 2024
Feb. 28, 2024Philips Allura Xper Interventional Fluoroscopic X-ray Systems… and 1 more productClass IIDisk Bay may not perform as intended. System may stop functioning and imaging may not be possible, resulting in delay of procedure. Recall began Jan. 2, 2024
Feb. 21, 2024FilmArray Gastrointestinal (GI) Panel RFIT-ASY-0116 (30 test kit) RFIT-ASY-0104 (6 test kit) Gastrointestinal…Class IIDue to potential signals of increased false positive Norovirus results when using the gastrointestinal (GI) panel.
Feb. 21, 2024BIOFIRE Blood Culture Identification 2 (BCID2) Panel when used with: BD BACTEC Lytic Anaerobic medium BD…Class IIDue to a trend in false positive Candida tropicalis results on blood culture panel when using certain BD BACTEC vial mediums
Feb. 21, 2024Samsung Digital Diagnostic Mobile X-ray System…Class IIMobile x-ray systems moving arm frame welding issue which presents the potential of bodily harm due to fall of the arm. Recall began Dec. 28, 2023
Feb. 14, 20245 oz 2pk Chocolate Croissant… and 4 more productsClass IIProduct contains undeclared soy lecithin. Recall began Jan. 12, 2024
Feb. 14, 2024Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023…Class IIThe device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. Recall began Jan. 11, 2024
Feb. 14, 2024Total immunoglobulin M (IgM total) IVD…Class IIPotential for a negative bias with quality control (QC) and patient sample results when using the Atellica CH Immunoglobulin M_2 (IgM_2) reagent. Recall began Dec. 15, 2023
Feb. 14, 2024Sperm separation media are used to separate motile sperm from other constituents of semenClass IIThe lower layer component of a sperm separation Kit does not match the certificate of analysis. The kit should contain lower layer (Lot: 0000020686… Recall began Nov. 2, 2023
Feb. 14, 2024FilmArray Pneumonia Panel Plus (Pneumoplus)… and 1 more productClass IITheir is a potential for false positive results when using Pneumonia panel. Recall began Dec. 14, 2023
Feb. 14, 2024Flow-i C20 Anesthesia System… and 4 more productsClass IIPotential cybersecurity vulnerability that could lead to a Denial of Service (DoS) attack, tampering, or remote code execution via remote login to… Recall began Dec. 11, 2023
Feb. 7, 2024VIVA for cats duck… and 3 more productsClass IFDA notified the firm that via our Adverse Event Reporting system that a positive test results for Listeria monocytogenes and Salmonella was found in…
Jan. 31, 2024Duc De Coeur Camembert Cheese Croquettes Frozen…Class IIPossible contamination with Listeria monocytogenes
Jan. 31, 2024Outrageous Oat Cookies packaged in 5pk and also sold in BulkClass IProduct contains undeclared wheat.
Jan. 31, 2024TactiFlex Ablation Sensor Enabled Ablation Catheter…Class IIWhen the catheters are used with the EnSiteX EP System, the system does not correctly recognize the catheter as the appropriate product model and… Recall began Dec. 18, 2023
Jan. 24, 2024Ministry of Snacks Sweet and Savory Collection #8700Class IPotential Salmonella contamination of Quaker Oats Chewy Granola Bars packed in gift baskets. Recall began Dec. 19, 2023
Jan. 24, 2024INDICAID COVID-19 Rapid Antigen At-Home Test…Class IICOVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21… Recall began Oct. 25, 2023
Jan. 17, 2024BD Recanalization System…Class IIRecanalization systems may be in a manufacturing mode that allows the system to continuously run without the typical 30 second pauses, and 4-minute… Recall began Nov. 14, 2023
Jan. 17, 2024CUSTOM SPRYSTEP… and 2 more productsClass IIDue to potential air pockets between layers of material, their is the potential for complete struct breakage of knee-ankle-foot orthosis. Recall began Sept. 23, 2023
Jan. 17, 2024Bard Mission Disposable Core Biopsy Instrument Kit (REF/Name): 1410MSK/ Mission Kit 14G x 10CM…Class IIThe internal diameter of the coaxial cannula may be smaller or larger than the external diameter of the biopsy needle, and the length of the cannula… Recall began Nov. 8, 2023
Jan. 17, 2024CD11b APC: ASR…Class IIIn vitro diagnostics product that impacts the quality of cell staining can cause low or dim fluorescence signal, which can lead to potential false… Recall began Oct. 25, 2023
Jan. 10, 2024External Drainage System Collection Bag… and 1 more productClass IISterility assurance cannot be guaranteed for external drainage systems due to incomplete bioburden testing. Recall began Nov. 28, 2023
Dec. 27, 2023Injection Needle… and 4 more productsClass IIThe efficacy of the manual cleaning process cannot be assured for the affected injection needles intended for general surgery and visceral surgery… Recall began Oct. 24, 2023
Dec. 27, 20230.9% Sodium Chloride: Brand Name: Product Name/Product Code: MAC… and 4 more productsClass ISodium chloride irrigation USP, and sterile water for irrigation USP, that may be packaged inside kits, have the potential for a lack of sterility… Recall began Nov. 6, 2023
Dec. 20, 2023Acorn Raspberry Creme Filled Cookie found in gift basket: #067… and 8 more productsClass IUndeclared allergens; tree nuts
Dec. 20, 2023CereLink ICP Extension Cable (Extension Cable)…Class IFirm is expanding the existing recall RES 90457 for the Cerelink, initiated in June 2022, to include all CereLink ICP Extension Cables. The updated… Recall began Oct. 5, 2023
Dec. 13, 2023Whole cantaloupe… and 1 more productClass IThe affected product is being recalled from the marketplace due to possible Salmonella contamination. Recall began Nov. 6, 2023
Dec. 13, 2023BIOFIRE Blood Culture Identification 2 (BCID2) Panel…Class IIRoutine quality control testing of affected blood culture identification panel with affected control panel may need to be amended, due to control… Recall began Oct. 17, 2023
Dec. 13, 2023Monarch Platform REF MON-000005-01… and 2 more productsClass IITheir is the potential that software issues may result in flipped image of the virtual Bronchoscope view. Recall began Oct. 18, 2023
Dec. 13, 2023CARDIOHELP Emergency Drive…Class IProduct removal due to possible blocking or impairment of the CARDIOHELP Emergency Drive. This issue can lead to the patient being exposed to… Recall began Oct. 10, 2023
Dec. 6, 2023Breakfast Sandwich Bacon Egg & Cheddar Croissant… and 4 more productsClass IUndeclared milk and soy Recall began Nov. 3, 2023
Dec. 6, 2023Acumen IQ Sensor… and 5 more productsClass IITheir is the potential for flushing difficulties during setup of the pressure monitoring kit with pressure transducer. Recall began Oct. 4, 2023
Nov. 29, 2023EXALT Model D Single-Use Duodenoscope: Outer box UPN# M00542420 &… and 1 more productClass IIPoor image quality due to fluid ingress in the lens. Recall began Sept. 27, 2023
Nov. 29, 2023FilmArray TORCH REF HTFA-ASY-0104…Class IIDue to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up… Recall began Oct. 17, 2023
Nov. 29, 2023BD Alaris Pump infusion sets (Product Name… and 2 more productsClass IIAffected infusion sets labeled as free of DEHP actually do contain di(2-ethylhexyl) phthalate (DEHP). Recall began Oct. 11, 2023
Nov. 15, 2023Frozen and fresh RTE Lobster meat (1 lb…Class ILobster meat may be contaminated with Listeria monocytogenes. Recall began Oct. 9, 2023
Nov. 15, 2023StealthStation S8 Application version 2.0 and 2.0.1 (Part 9735762) The StealthStation System…Class IDue to a software anomaly which potentially could result in the surgical planning data shifting to an unintended location. Recall began Sept. 27, 2023
Nov. 15, 2023BD Alaris PCU REF 8015 and 2 more productsClass IAlaris PCA Module 8120, Patient Controlled Analgesia infusion pump: compatible syringes labeling contains syringes that have not been validated. Recall began Sept. 15, 2023
Nov. 8, 2023Wegman's Organics Sweet Kale Chopped Salad Kit…Class IUndeclared egg
Nov. 1, 2023Organic Protein & 50 Superfoods Protein Powder with Probiotic…Class IUndeclared allergen; sesame Recall began Sept. 28, 2023
Nov. 1, 2023Whole cantaloupe…Class IPossible contamination with Salmonella spp. Recall began Sept. 22, 2023
Nov. 1, 2023SOZO Bilateral Arm L-Dex SoftwareClass IIBilateral L-Dex assessment software does not have the same level of sensitivity to help detect early signs of lymphedema as the unilateral arm L-Dex… Recall began Aug. 17, 2023
Nov. 1, 2023TruDi Navigation System…Class IIWhen using affected curette and software, there is a discrepancy between the actual curette tip location and the location displayed on navigation… Recall began Sept. 21, 2023
Nov. 1, 2023Astral 100 and Astral 150 ventilatorsClass IIf ventilator is on internal battery, not intended to serve as a primary power source, low/critically low battery alarms will sound, but a fault… Recall began Sept. 13, 2023
Oct. 25, 2023Sunnyside Farms…Class IISafeway Fresh Foods of Vineland, NJ, is recalling its 32-oz. Diced Organic Butternut Squash product as it has the potential to be contaminated with… Recall began Sept. 15, 2023
Oct. 18, 2023LittleOak Natural Goat Milk Infant Formula (Stage 1)… and 1 more productClass IINo pre-market notification and Mixing instructions not in ounces Recall began Sept. 11, 2023
Oct. 18, 2023Procedure packs: (1) Presource Pain Tray… and 9 more productsClass IIPacks contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits). Recall began Aug. 16, 2023
Oct. 18, 2023CellQuicken Analyzer (Smart-Watch and Software)…Class IIUltrasound devices were not authorized, cleared, or approved by FDA, and thus their performance characteristics have not been adequately established.… Recall began Aug. 30, 2023
Oct. 11, 2023Heartmate 3 LVAS Implant Kit…Class IIInability to start and/or complete the coring procedure due to inadequate sharpness of the Apical Coring Knife, provided with Left Ventricular Assist… Recall began Aug. 7, 2023
Oct. 4, 2023Life Raft TREATS ICE CREAM NOT FRIED CHICKEN Hand Crafted in… and 1 more productClass ISouth Carolina Department of Health discovered the product contained Listeria monocytogenes.
Sept. 27, 2023Philips Tempus Pro Patient Monitor…Class IIFull screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from… Recall began Aug. 24, 2023
Sept. 27, 2023Five S 5 3x65…Class IIFlexible intubation endoscopes sterility assurance can not be confirmed. Recall began July 7, 2023
Sept. 20, 2023FILMARRAY Gastrointestinal (GI) Panel (Part No.: RFIT-ASY-0104 & RFIT-ASY-0116) Pouch Module SoftwareClass IIThe firm has identified an increased risk of obtaining false positive Cryptosporidium results from customers using the BIOFIRE FILMARRAY… Recall began April 25, 2023
Sept. 20, 2023Proclaim XR 5 Implantable Pulse Genterator REF 3660 (previously known… and 6 more productsClass IFirm has received complaints from patients who are unable to exit MRI (Magnetic Resonance Imaging) mode on their IPGs (Implantable Pulse Generators). Recall began July 18, 2023
Sept. 13, 2023ISee Ortho-K Lens and 1 more productClass IIManufactured lenses are not covered by existing FDA approval Recall began June 26, 2023
Sept. 6, 2023Beckman Coulter…Class IILipemic interference failed to meet the performance specification listed within the IFU. Recall began July 12, 2023
Sept. 6, 2023epoc BGEM BUN Test Card with epoc Host SW v3.37.3… and 2 more productsClass IIThere is potential for discrepant high glucose results in samples with glucose results on the lower end of the reportable range. Recall began June 1, 2023
Aug. 30, 2023Soft Serve on the Go brand Vanilla Chocolate flavor… and 4 more productsClass IProduct may be contaminated with Listeria monocytogenes.
Aug. 30, 2023Green Curry Paste (one ounce) 28g contained in Every Plate meal code 87…Class IIProduct spoiled due to temperature abuse. Recall began July 21, 2023
Aug. 23, 2023Alpenfest Style Sachertote…Class IIUndeclared Egg, Milk, Wheat Recall began July 14, 2023
Aug. 16, 2023Caramel Butter Pecan Cup 14 fl oz…Class IIPotential ink pen pieces; foreign object. Recall began June 30, 2023
Aug. 16, 2023Randox RX Series Urea Enzymatic Kinetic Assay Ref…Class IICarryover from the Direct LDL-cholesterol assay on the Rx instruments may result in a negative bias, up to -11%, in quality control and patient… Recall began June 13, 2023
Aug. 9, 2023OEC Flexiview 8800 Systems with 9-inch Image Intensifier and 4 more productsClass IIImage intensifiers on systems, used to provide fluoroscopic/digital spot images can become detached if the systems encounter a large impact force… Recall began May 15, 2023
Aug. 2, 2023QIAstat-Dx Respiratory SARS-CoV-2 Panel -US IVD qualitative test… and 1 more productClass IIIdentified a decreased performance reliability rate, Run abortions could cause delayed diagnosis since sample testing would have to be repeated Recall began May 19, 2023
Aug. 2, 2023QIAstat-Dx Respiratory SARS-CoV-2 Panel -IVD intended for the detection and differentiation of nucleic acid…Class IIIf cartridges of the affected Serial numbers (SNs) are used, in most cases, the error codes 0xY0003EA and 0xY00045A (where Y is a number between 1… Recall began May 9, 2023
July 26, 2023Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2…Class IIDura regeneration matrix may have out-of-specification endotoxin levels due to issues with in-process and finished goods endotoxin testing, which may… Recall began June 13, 2023
July 26, 2023Simplexa Direct Amplification Disc Kit…Class IIThere is a potential for the direct amplification disc to malfunction which may result in spillage of liquid from the disc. Recall began June 14, 2023
July 26, 2023Aesculap Surgical Needle…Class IIIncorrect product code marked on the product, etched with product code MD611, however; the correct product code is MD610. Recall began May 18, 2023
July 12, 2023BD Pyxis CII Safe…Class IIAutomated dispensing cabinet devices plugged into any multi-socket outlet power strips may present unacceptable levels of current leakage, which… Recall began May 22, 2023
July 12, 2023da Vinci Xi/X Tip-Up Fenestrated Grasper…Class IIFenestrated Graspers have a manufacturing issue has the potential to cause breakage on both upper and/or lower grips, which could lead to stainless… Recall began June 12, 2023
June 28, 2023enterade Advanced Oncology Formula…Class IIPotential for the product to develop mold and spoil. Recall began May 25, 2023
June 28, 2023Wegmans Italian Classics Diavolo Pasta Sauce 24 OZClass IProduct may contain undeclared fish. Recall began May 16, 2023
June 28, 2023Metal Tray…Class IIMetal sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for the… Recall began April 6, 2023
June 28, 2023Masimo RD Set TC-I SpO2 Adult Reusable Ear Sensor… and 3 more productsClass IITC-I tip clip sensor may produce readings outside the accuracy specification. Recall began April 21, 2023
June 28, 2023KARL STORZ Radel Sterilization Trays…Class IIPlastic sterilization trays used to encase and protect medical devices during sterilization have a new 510(k) with instructions for use that is for… Recall began April 5, 2023
June 21, 2023Van Leeuwen brand BROWN SUGAR CHUNK WITH COOKIE DOUGH & BROWNIES FENCH ICE CREAM…Class IProduct may contain undeclared walnuts. Recall began May 22, 2023
June 21, 2023Driver Instrument…Class IIPending update to indirect decompression system instructions for use informing users that excessive force during the implant procedure may cause… Recall began May 12, 2023
June 21, 2023Aspira Peritoneal Drainage Catheter Insertion Tray 15.5F… and 12 more productsClass IIThere is a potential that valve assemblies will not open. preventing fluid from draining. Recall began April 22, 2023
June 14, 2023StealthStation Cranial Software…Class IDuring non-axial/some axial exams, software anomalies occur during procedures affecting depth gauge graphic displays for cranial biopsy; causing… Recall began April 11, 2023
May 31, 2023Copitas…Class IIProduct may exceed FDA guidance levels for leachable lead. Recall began May 1, 2023
May 24, 2023Beckman Coulter Bicarbonate… and 2 more productsClass IIThere is a potential for a decrease in calibration ODs for Bicarbonate reagent which could result in calibration failures and/or quality control… Recall began April 5, 2023
May 17, 2023Bard Mission Disposable Core Biopsy Instrument Kit: REF: 2010MSK…Class IICoaxial cannula internal diameter and length of biopsy instruments exceed the external diameter and length of the biopsy needle, prohibiting the… Recall began April 11, 2023
April 26, 2023FilmArray Gastrointestinal (GI) Panel for FILMARRAY Systems…Class IIDue to manufacturing issue, Gastrointestinal (GI) Panel may result in false negative results. Recall began March 8, 2023
April 26, 2023Shiley Adult Flexible Tracheostomy Tube with TaperGuard Cuff…Class IA manufacturing error, resulted in a less than specified diameter of adult flexible tracheostomy tube connectors, which results in unsecure… Recall began March 24, 2023
April 19, 2023Edward Lifesciences… and 1 more productClass IIThere is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device… Recall began Feb. 14, 2023
April 12, 2023Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically…Class IIDuring internal testing, Regulatory Compliance issues were identified regarding the Monitor and Power Supplies for fluid ingress and basic safety… Recall began Feb. 23, 2023
April 5, 2023ISH Shrimpish Sample Meal Kit: ( Sample Meal Kit ) a package containing two ISH Foods plant-based Shrimpish…Class Iundeclared soy proteins Recall began Jan. 9, 2023
April 5, 2023Color Cuff Single Port…Class IIIncreased incidence of disposable tourniquet cuffs "not able to achieve desired pressure" and "not holding pressure" due to 1) Cuff fabric tearing… Recall began March 1, 2023
April 5, 2023Irvine Scientific Oil for Embryo Culture (Light Mineral Oil) REF Catalog # 9305Class IIDue to the detection of oil toxicity in several lots of Oil for Embryo Culture products. Recall began Jan. 16, 2023
March 29, 2023BD Pyxis Anesthesia ES System (PAS ES)…Class IIAutomated dispensing cabinet drawer firmware may have inadvertently been downgraded to an earlier version of drawer firmware during new device… Recall began Feb. 14, 2023
March 22, 2023Bistro to Go… and 408 more productsClass IOn 02/03/2023, FRESH IDEATION FOOD GROUP, LLC dba Fresh Creative Cuisine of Baltimore, MD is initiating a recall of various products sold from… Recall began Feb. 3, 2023
March 22, 2023Tapas Cocktail White Tiger Shrimp…Class IPossible contamination with Listeria monocytogenes.
March 22, 2023Bard Mission Disposable Core Biopsy Instrument Kit: 16G x 10CM…Class IIThe external diameter of the biopsy instrument is larger than the internal diameter of the coaxial needle, which could lead to: 1) Procedural delay…
March 22, 2023Recreo Hair Growth Laser CombClass IIThe firm distributed the laser products without affixing the warning, aperture, certification, and identification labels. In addition, the firm… Recall began Sept. 1, 2022
March 15, 2023Given Imaging SmartBar Cereal Bar…Class IICereal bar may be contaminated with tobacco beetles. Recall began Feb. 2, 2023
March 15, 2023Simplexa COVID-19 Direct… and 1 more productClass IIDirect amplification Discs , used with COVID-19 and Flu A/B & RSV assays, may leak and cause contamination, cross-contamination, invalid results, and… Recall began Jan. 30, 2023
March 15, 2023Cardiosave Hybrid Model Nos… and 1 more productClass IAn unexpected shutdown of the IABP may occur due to loss of communication between the Executive Processor PCBA and the Video Generator PCBA. This may… Recall began Feb. 7, 2023
March 8, 2023Ultracell Wick with 80cc Collection Bag… and 1 more productClass IIDevice packaging may contain open seals, compromising product sterility. Recall began Dec. 20, 2022
March 8, 2023Alaris PC Unit 8015 utilizing 802.11 b/g or 802.11 a/b/g wireless network cards…Class IIInfusion pump PCs with specific software/network cards/IP addresses can have network/wireless connection failure. Could cause inability to receive… Recall began Jan. 24, 2023
Feb. 15, 2023The Covera Vascular Covered Stent is a flexible…Class IIAn increase in the reported complaint rate for inability to deploy was identified and related to poor slide block bonding. Recall began Dec. 22, 2022
Feb. 8, 2023Catalog Number / Product Description 0601600 2.7F Broviac CV Catheter Repair Kit 0601610 4.2 Fr Broviac CV…Class IIDue to the adhesive provided within the catheter repair kits maybe hardened/coagulated (unusable). Recall began Jan. 4, 2023
Feb. 8, 2023AxiEM" Non-Invasive Patient TrackerClass IIDue to increasing complaint trend for the Non-Invasive Patient Tracker system where complaints analysis indicates that users are unable to… Recall began Dec. 15, 2022
Feb. 1, 2023Chef Select 2 Garlic Baguettes filled With Garlic Butter 175 g… and 1 more productClass IIUndeclared wheat and milk allergens Recall began Dec. 2, 2022
Feb. 1, 2023Wegmans Organic Farm & Orchard Micro Greens… and 1 more productClass IIProduct(s) may be contaminated with Salmonella. Recall began Dec. 22, 2022
Feb. 1, 2023Getinge Flow-i Anesthesia Systems Flow-i C20… and 2 more productsClass IDue to a software bug, under certain conditions, pressure cannot be built up resulting in no ventilation. If gas delivery is stopped, a sustained… Recall began Dec. 22, 2022
Jan. 18, 2023ACME Smoked Nova Salmon… and 1 more productClass IIPossible pathogen grown and toxin formation in Salmon products Recall began Nov. 14, 2022
Jan. 18, 2023VENTANA PD-L1 (SP142) VENTANA PD-L1 (SP142) Assay (Class III…Class IIInternal comparison studies revealed unacceptable, light staining. Light staining affects the borderline of positive versus negative test results. It… Recall began Nov. 18, 2022
Jan. 11, 2023Wegmans Organic Farm & Orchard Cat GrassClass IIProduct may be contaminated with Salmonella.
Jan. 4, 2023Part Number/Part Description: 30-0033-S 30mm Acutrak Fusion Device… and 3 more productsClass IIDistribution without Pre-Market Clearance Recall began Nov. 29, 2022
Dec. 28, 2022King Oscar Anchovies Flat Fillet in Olive Oil 2 oz…Class IIAnchovies found to have elevated levels of histamine
Dec. 28, 2022Vivid S5 Ultrasound… and 7 more productsClass IIPotential for batteries that have not been replaced at 2 years, as recommended in the Service Manual, they can fail or possibly emit smoke, or catch… Recall began Nov. 10, 2022
Dec. 28, 2022The Natus Cranial Access Kit is designed to be a complete…Class IIDue to Cranial Access Kits containing recalled sterile surgical drapes. The sterile surgical drapes are being recalled due to the liner on the… Recall began Nov. 18, 2022
Dec. 21, 2022Cordis Angiographic Catheter Extensions…Class IIThere is a potential for separation at the male connector. Recall began Nov. 7, 2022
Dec. 14, 2022Nestle Toll House Edible Chocolate Chip Cookie Dough packaged in 15oz tubs…Class IIPotential of foreign material within product. Recall began Nov. 3, 2022
Dec. 14, 2022LineSider Spinal System pedicle screws…Class IIPotential for intraoperative screw head separation at weld location. Recall began Aug. 3, 2022
Dec. 14, 2022LineSider Spinal System 5.5/6.0mm… and 2 more productsClass IIPotential for weld separation of the Upper Tulip Head component from the Lower Tulip Head component, which would result in the separation of the… Recall began Jan. 27, 2022
Dec. 7, 2022Accelerate PhenoTest BC kit REF 10101018 and 1 more productClass IIDue improperly formulated and released bulk lot of fluorescence in situ hybridization (FISH) probes resulting in false positive identification… Recall began Oct. 17, 2022
Dec. 7, 2022CoViPoint COVID test kit (MultiPLEX/Direct) Kit Item Numbers: BC-DK0200…Class IIDistribution of COVID Test Kits without FDA Approval, Clearance or Authorization. Recall began Aug. 8, 2022
Nov. 23, 2022Pedialyte Unflavored Electrolyte Solution 2 fl oz plastic reclosable… and 11 more productsClass IICompromised seal integrity which could lead to spoilage Recall began Oct. 13, 2022
Nov. 23, 2022Visualase Cooled Laser Applicator System (VCLAS) 9735560 .4MM CORE FIBER 10MM TIP product…Class IIDue to a defect in the outer pouch sterile seal Recall began Oct. 14, 2022
Nov. 16, 2022Hammond's Salted Caramel Cookies…Class IPeanut Butter Chocolate Chip Cookies mispacked in Salted Caramel Cookies Box creating undeclared peanut allergen. Recall began Oct. 13, 2022
Nov. 16, 2022Insulin Pump/Model: MiniMed 630G/ MMT-1715… and 1 more productClass IIMedtronic identified a cybersecurity vulnerability in the MiniMed 600 series Insulin Pump Systems associated with the communication protocol that… Recall began Sept. 20, 2022
Nov. 16, 2022Zio AT Clinical Reference Manual…Class IIAmbulatory ECG monitoring system labeling update: 1) Clinically actionable arrhythmia notifications delayed until patient registration is complete… Recall began Sept. 28, 2022
Nov. 16, 2022NaturaLyte Liquid Acid concentrate…Class IIThe "Nominal Chemical Composition" section of the label incorrectly lists 5.62g/L KCL (potassium chloride). 5.62g/L actually corresponds to the CaCl… Recall began Oct. 4, 2022
Nov. 9, 2022BD Trucount Tubes (Cat… and 2 more productsClass IIDue to partial label detachment on tubes. This can cause tubes to become stuck together in the pouch or cause automation errors when used with the… Recall began Oct. 3, 2022
Nov. 9, 2022Fogarty Arterial Embolectomy Catheters Model Number: 120602FP… and 1 more productClass IIDue to an increase of confirmed latex deterioration complaints for arterial embolectomy catheters packaged in pouches. Recall began Oct. 6, 2022
Nov. 2, 2022THE CHAI BOX CHAI CONCENTRATE 16FL OZ/473ML glass bottles… and 1 more productClass IIIPotential to be contaminated with Clostridium botulinum. Product was tested and found to have pH level of 4.9. Recall began Sept. 23, 2022
Nov. 2, 2022GORE CARDIOFORM ASD Occluder…Class IIDue to manufacturing records (Release Test Results) indicating "Failed". Recall began Sept. 21, 2022
Nov. 2, 2022Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray…Class IIPrinted Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and… Recall began Sept. 20, 2022
Oct. 26, 2022Mrs. Freshley's Apple Fruit Pie… and 5 more productsClass IIDuring an internal inspection the firm discovered that several products may contain soy lecithin which is not declared on the labels.
Oct. 26, 2022"***Nestle***STUFFED***CHOCOLATE CHIP COOKIE DOUGH***4 JUMBO COOKIES***…Class IIConsumer complaints reported presence of white pieces of plastic in cookie product.
Oct. 26, 2022Seeking Health brand Optimal Multivitamin Chewable Dietary Supplement tablets…Class IIThe product label claim for copper is 0.5mg, but third-party lab results revealed product contains higher levels of copper. Recall began Sept. 16, 2022
Oct. 26, 2022Product/Part: MitraClip XTR Clip Delivery System US/CDS0601-XTR… and 2 more productsClass IIAn increase in clip locking malfunctions, Establish Final Arm Angle and Clip Opening While Locked, have been observed. Contributing causes may be… Recall began Sept. 8, 2022
Oct. 12, 2022Philips Respironics Amara View Minimal Contact Full-Face Mask and 4 more productsClass INo contraindication/warning regarding magnetic components in CPAP masks for patients with implantable devices or metallic splinters in the eyes. Recall began Sept. 6, 2022
Oct. 5, 2022Aged raw milk cheese "Ploughman Cider Wash Tomme" batch 47 4 oz to 12… and 9 more productsClass IAll products manufactured by the firm have the potential to be contaminated with Listeria monocytogenes. Recall began Aug. 25, 2022
Oct. 5, 2022"A&W Root Beer Zero Sugar" packaged in 20oz PET bottles…Class IIProduct contains undeclared sugar. Full sugar root beer was packaged in bottles labeled "sugar free" Recall began Aug. 26, 2022
Oct. 5, 2022MEDLINE CLEARPRO DOUBLE SWIVEL CLOSED SUCTION CATHETER… and 2 more productsClass IIPotential for the suction catheter to come apart from the green connector near the thumb valve. The connector is coming apart from the assembled… Recall began Aug. 3, 2022
Oct. 5, 2022Ambra PACS…Class IIA race condition between the storage system and services database has the potential to revert edits made to patient information upon first ingestion… Recall began June 23, 2022
Oct. 5, 2022t:slim X2 insulin pump… and 1 more productClass IIInsulin pumps may have the following issues: 1) Malfunction 6 Non-Volatile Memory, 2) Inaccurate (Fluctuating) Battery Life Display, 3) Touchscreen… Recall began May 24, 2022
Sept. 28, 2022Puritan Bennett 560 Ventilator…Class IIMedtronic has confirmed six reports from customers outside the US where the ventilator became inoperable due to loss of gas supply caused by… Recall began Aug. 19, 2022
Sept. 28, 2022AquaC UNO H [120V… and 1 more productClass IIInternal ethemet cables are missing one or both ferrite cores therefore the electromagnetic compatibility of the device is not ensured Recall began June 21, 2022
Sept. 21, 2022QIAcube Connect MDx…Class IIDuring the "Load tip racks and enzymes" step of the run set-up, the info screen indicates "minimal volume to be loaded", but the indicated volume is… Recall began Nov. 21, 2021
Sept. 21, 2022MicroClave Clear Neutral Connector… and 5 more productsClass IIDue to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. Recall began Aug. 1, 2022
Sept. 7, 2022Sweetums 24% sucrose solution preservative free… and 1 more productClass IIFirm received complaints of leaking, black liquid, and black particulates in the product vials. Recall began July 19, 2022
Sept. 7, 2022Wegmans Lemon Dill Finishing Butter…Class IFirm's supplier of frozen dill notified firm of a recall due to potential contamination with Listeria monocytogenes.
Sept. 7, 2022T-SPOT.TB REF TB.300 US and 2 more productsClass IIDue to equipment failure, affected products were stored at temperatures outside the validated range of 2-8 degree C for a period longer than the… Recall began July 7, 2022
Aug. 31, 2022Vanta Clinician Programmer Application…Class IIPotential communication issue in which the Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 may be unable to connect with a Vanta… Recall began July 26, 2022
Aug. 31, 2022Vanta Clinician Programmer Application…Class IIPotential for Vanta Clinician Programmer Application (CP App) A71200 v2.0.2455 to display an Unexpected Device Error Code 1502 Message, and the user… Recall began July 26, 2022
Aug. 24, 2022Ready Meals Shrimp Cooked with Cocktail Sauce SCE… and 2 more productsClass IUndeclared allergens; fish and shellfish Recall began July 13, 2022
Aug. 17, 2022cobas e801 Immunoassay AnalyzerClass IISoftware issue resulting in signals and sample test results of Pre-Wash tests being impacted. The following assays are considered impacted by the… Recall began July 14, 2022
Aug. 10, 2022UroLift System REF UL400-4…Class IIThere is the potential that during implant deployment, the device may not properly deliver a implant. Recall began June 24, 2022
Aug. 10, 2022Merlin PCS 3650 programmer Model 3330 software and 2 more productsClass IIThere is a potential for programmer software (Merlin PCS) and remote monitoring software application (Merlin.net) to display overestimated predicted… Recall began June 17, 2022
Aug. 10, 2022PRESTIGE ATRAUMATIC GRASPER W/PORT DUAL ACTION… and 1 more productClass IIEndoscopic graspers may become separated at the weld from handle to the shaft of the device. Recall began April 1, 2020
Aug. 10, 2022SARS CoV 2 rapid antigen test kits packaged under the following brands: Oral Rapid Test…Class IVarious brands of SARS CoV 2 Antigen Rapid Test kits were offered for sale and distribution to consumers in the United States without marketing… Recall began June 15, 2022
Aug. 3, 2022Da Vinci S/Si Large Clip Applier… and 1 more productClass IIDue to the potential for unexpected motion caused by the partial disengagement of the instrument from the system. Recall began July 1, 2022
July 27, 2022Trevo Trak 21 Microcatheter…Class IIMicrocatheter product label on the carton is missing the microcatheter product drawing/illustration. Recall began June 3, 2022
July 20, 2022Wawa COLD BREW COFFEE***ONE PINT (473ML)***MADE WITH WAWA COLD BREW***Nutrition Facts***INGREDIENTS: CREAM…Class IProduct is being recalled due to undeclared peanuts. Recall began June 7, 2022
July 20, 2022Ventana HE 600 System…Class IIThere is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire Recall began June 1, 2022
July 20, 2022PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System…Class IIPotential for stent dislodgement and associated failures related to two specific sizes of the device. Recall began May 20, 2022
July 20, 2022MiniMed 620G Insulin Pump (O.U.S… and 7 more productsClass IIDue to battery cap deterioration, this may potentially result in an incomplete battery circuit (similar to when battery cap is not attached) and a… Recall began May 23, 2022
July 20, 2022CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000 and 4 more productsClass IIExecuting a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical… Recall began June 9, 2022
July 13, 2022ABL800 Flex Analyzer Model Numbers 393-800 and 393-801Class IIThere is a potential for sporadic incidents of positive and negative biases for analyzer systems configured with cNa+, cCa+, and cK+. Recall began May 18, 2022
July 13, 2022Palindrome Precision Chronic Catheter… and 8 more productsClass IThere is a potential leaking condition within the hub of specific chronic dialysis catheters, due to an inter-lumen void in the hub component, which… Recall began June 8, 2022
July 6, 2022Snack Fresh Apples and Peanut Butter… and 4 more productsClass IPotential to be contaminated with Salmonella Recall began May 22, 2022
July 6, 2022Volcano Visions PV… and 1 more productClass IIIDigital IVUS catheter instructions for use ( IFU) do not contain contrainidications Recall began May 13, 2022
July 6, 2022QMS Tacrolimus Immunoassay REF 10015573 CALIBRATOR SET QMS TACROLIMUS CAL A 10015566-3 QMS TACROLIMUS CAL B…Class IIDue to QMS Tacrolimus Calibrator recovering between 82 to 94% of their target values, resulting in over-quantitation in tacrolimus patient result… Recall began Jan. 20, 2022
June 29, 2022Trader Joe's BBQ & Black Pepper Toscano Chopped Salad 11 oz…Class IIUndeclared allergen (peanuts) from incorrect master pack. Salad kit contains chopped roasted peanuts and peanut lime dressing.
June 29, 2022BVI Wet -Field Eraser…Class IIBoxes labeled as Wet-Field Eraser, 18GA Blunt Tip, 45Deg., were shipped containing incorrect product a Wet-Field Eraser, 18GA Bevel Tip, Straight… Recall began April 26, 2022
June 22, 2022Wawa Apples & Peanut Butter 4.9oz…Class IPossible contamination with Salmonella Recall began May 23, 2022
June 22, 2022Cobalt Models loaded with CareLink SmartSync Device Manager… and 1 more productClass IITelemetry error that may occur with Medtronic Cobalt and Crome implantable cardioverter defibrillators (ICDs) and cardiac resynchronization therapy… Recall began April 12, 2022
June 22, 2022illumina REF DX-410-1001 Model: MiSeq Dx illumina REF 15036706 Model… and 1 more productClass IIcybersecurity vulnerability Recall began May 3, 2022
June 15, 2022Taharka Brothers Peanut Butter Cup Ice Cream 16 oz Pint Container: Paper cup with peanut butter cups along…Class IMay be contaminated with Salmonella
June 15, 2022Trader Joe's Southwestern Chopped Salad Contains: Green Cabbage…Class IITrader Joes branded Southwestern Chopped Salad Kits was found to contain the incorrect master pack. The master pack includes the allergens of soy and…
June 15, 2022Centricity Universal Viewer Zero Footprint Client and 4 more productsClass IIPotential for Distance and Area measurements to display inaccurate measurement values when performed on magnified images, and specific to ZFP… Recall began April 28, 2022
June 8, 2022DYNEX Agility…Class IIControl samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that… Recall began July 5, 2020
June 8, 2022BD Anti-Kappa APC (Cat… and 1 more productClass IIAnti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles. Recall began March 25, 2022
June 8, 2022The C304-HIS device features a guide wire to access the vein…Class IIThe firm's internal processes identified that certain lots may have an improperly sealed barrier that could potentially compromise sterility. Recall began April 20, 2022
June 1, 2022Percept BrainSense Implantable Neurostimulator (INS)… and 1 more productClass IIThe Implantable Neurostimulator (INS) cannot communicate with the clinical programmer and/or the patient programmer system. Recall began March 30, 2022
June 1, 2022Vanta INS Implantable Neurostimulator…Class IIThe Implantable Neurostimulator Model may be susceptible to not communicating with the clinical programmer and/or patient programmer system. Recall began March 30, 2022
May 25, 2022Driscoll's Blackberries (Fresh) 12x6 oz…Class IIICalifornia Department of Pesticide Regulation detected the presence of Formetante HCI. This pesticide has a non-tolerance for blackberries. Recall began April 15, 2022
May 25, 2022Radiometer…Class IIArterial Blood Sampler sterility cannot be guaranteed throughout the shelf life of the product. Recall began April 8, 2022
May 25, 2022Dragonfly OpStar Imaging Catheter…Class IThere is a potential that the proximal marker may separate from the imaging catheter Recall began March 30, 2022
May 25, 2022MicroScan WalkAway-40 plus Instrument REF B1018-283 and 5 more productsClass IIWalkAway Instruments may have been assembled with the incorrect AC power entry connector inlet with is rated at 1 ampere current rating rather than… Recall began Oct. 21, 2019
May 25, 2022Getinge 9100-Series Washer Disinfector models: 9120E…Class IIInadequate documentation verifying whether device installation has been executed in accordance with the manufacturer's requirements. This can lead to… Recall began April 1, 2022
May 18, 202212/5 oz. bags of O-Organic Sea Salt Popcorn. UPC Code: 79893403038Class IIA potato stick snack with a milk allergen was found in the O-Organic Sea Salt Popcorn line's recycle chute. Recall began April 9, 2022
May 18, 2022CYSTO-URETHRO-FIBERSCOPE REF 11272C1 CYSTOSCOPE… and 9 more productsClass IIFailure to achieve the expected six-log reduction in microorganisms following the disinfection process. Recall began April 1, 2022
May 18, 2022putty i-FACTOR Peptide Enhanced Bone Graft 1.0cc Syringe REF 700-010…Class IIIPatient chart label contains incorrect Part Number and volume amount. Recall began April 14, 2022
May 18, 2022Medtronic IN.PACT Admiral… and 1 more productClass IIPackaging for Balloon Catheters may be damaged resulting in loss of sterility. Recall began March 23, 2022
May 4, 2022Organic Marketside Zucchini 2 Count packages/8 per case Ingredients: Organic Zucchini New WT…Class IProduct may be contaminated with Salmonella
May 4, 2022RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001…Class IIPotential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software. Recall began March 9, 2022
May 4, 2022TearCare version 1.0 SmartHubsClass IIOphthalmic devices distributed prior to the recently-obtained 510(k) clearance do not fall within the relevant 510(k) exemption and so their… Recall began March 23, 2022
May 4, 2022da Vinici X da Vinci Xi Sureform 45 REF 480445 da Vinci X da Vinci Xi Sureform 45 Curved-Tip REF 480545 da…Class IIAs a result of complaint data review, it identified tissue pushout events occurring during firing of the SureForm stapler when tissue is pushed… Recall began March 17, 2022
April 27, 2022Merlin PCS 3650 programmer Model 3330 software and 1 more productClass IIDue to a programmer software anomaly under very specific circumstance when executing a pacing capture Decrement Test in-clinic on implantable… Recall began March 10, 2022
April 27, 2022Matrix Clinical Solution At-Home COVID-19 TestClass IIDue to COVID-19 Test not being authorized for home sample collection. Recall began Jan. 24, 2022
April 27, 2022Philips Respironics V60 Ventilator (All Models… and 2 more productsClass IVentilator units have an issue impacting an internal electrical circuit within the ventilators, that in some cases could result in the ventilator… Recall began Feb. 28, 2022
April 20, 2022ARIA Radiation Therapy Management (RTM) VERSIONS 13.6…Class IISoftware issue for treatment plan and image management application may result in mismatch values which could result in treatment in the wrong location Recall began March 21, 2022
April 20, 202220/30 INDEFLATOR -REF 1000184 WPL2122268-01 (2019-03-01) and 4 more productsClass IIDue to an increase in complaint trend for leaks and intermittent/loose connections. Recall began March 11, 2022
April 20, 2022MM-TSM (Touch Screen Module/Secondary Controller/Bedside Controller)…Class IIIMulti-Modality Touch Screen Modules (MM-TSM), used with integrated IVUS systems, may crack, or become damaged, which may affect their usability. They… Recall began Feb. 3, 2022
April 20, 2022Access-9 Large Bore Hemostasis Valves… and 1 more productClass IIA design change made to a hemostasis valve to improve manufacturability caused an internal gap between the rotator and the Y-body, where the… Recall began March 1, 2022
April 13, 2022BenchMark ULTRA and DISCOVERY ULTRA InstrumentsClass IIPotential for Fluid Leak inside a staining system that could cause an electrical short circuit of the General Purpose Input/ Output Board's J1… Recall began Jan. 20, 2022
April 13, 2022Brius Pontics (components in a set of custom metal orthodontic… and 2 more productsClass IIPontics, brackets, and customized orthodontic appliances were sold and distributed prior to completing the standard design control process, being… Recall began Feb. 7, 2022
April 13, 2022SyncVision Systems…Class IIIf FFR measurement(s) are made prior to an iFR/FFR co-registration/pullback in the same procedural session, this could result in incorrect iFR/FFR… Recall began Jan. 19, 2022
April 6, 2022MiniMed 630G: MMT-1715…Class IINew or replacement insulin pumps are not pre-programmed with basal rates or other verified settings (bolus wizard settings, sensor settings, etc.)… Recall began Jan. 27, 2022
April 6, 2022RayStation 4-11B…Class IIIncorrect source to skin or surface distance (SSD) calculation may result in dose error when using RayStation system. Recall began Feb. 11, 2022
April 6, 2022FORE-SIGHT ELITE Absolute Tissue Oximeter… and 1 more productClass IIThe StO2 values may be inaccurately low when using either the FORE-SIGHT ELITE Tissue Oximeter Module or the FORE-SIGHT ELITE Absolute Tissue… Recall began March 1, 2022
April 6, 2022(a) CareFusion Snowden-Pencer Plastics…Class IIThe finished device package did not contain the IFU. Recall began Feb. 23, 2022
April 6, 2022MiniCap Extended Life PD Transfer Set Product Codes: 5C4482S…Class IIDevices distributed lacked regulatory clearance. Recall began Feb. 25, 2022
April 6, 2022Liko Universal Twinbar 670 QRH…Class IIAn incorrect center bolt was used in the assembly of the product which could result in a patient fall during use. Recall began Feb. 21, 2022
April 6, 2022Mevion S250 and S250i Proton Therapy Systems hand pendant (P/N 10263 or P/N 37808)Class IIMalfunction of the hand pendant controlling movement of the therapy couch and nozzle may result in unintentional motion. Patient injury is possible… Recall began Feb. 1, 2022
March 30, 2022Outset Tablo Console Model Number: PN-0003000 Model Number: PN-0006000Class IIDue to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device. Recall began Jan. 20, 2022
March 23, 2022Taiyaki Variety Pack…Class IIHazelnuts were declared in ingredient statement but not in Contains statement. Recall began Feb. 17, 2022
March 23, 202214" Raw Buttermilk Breakfast Tart with Cranberries… and 1 more productClass IUndeclared almonds
March 23, 2022Safe-T PLUS Pediatric/Infant Lumbar Puncture Tray… and 10 more productsClass IIDue to lumbar puncture tray manometer failure mode of leaking and mating issues. Recall began Jan. 20, 2022
March 23, 2022Mycoplasma genitalium Control Panel (Inactivated Pellet)Class IIDistributed product did not undergo proper release testing.
March 23, 2022Panther Fusion Extraction Reagent-X…Class IIFailed stability specifications for reagent kits that may result in false negative test results. Recall began Jan. 27, 2022
March 16, 2022Factor 75…Class IIUndeclared Milk Allergen
March 16, 2022CIRRUS HD-OCT…Class IIOptic nerve head angiography scan to be turned off due to its distribution without pre-market clearance. Recall began Jan. 14, 2022
March 9, 2022Whole Foods Market Vanilla Short Bread Cookies packaged in clear plastic container with a white scale label…Class IUndeclared egg Recall began Feb. 3, 2022
March 9, 2022Favorite Day Carrot cake soft bake cookies…Class IIPecans although listed in the Ingredient Statement, was omitted from the CONTAINS statement.
March 9, 2022Alinity m Integrated Reaction Units (IRU)Class IIThere is potential for the Reaction Vessels (RVs) detaching from the RV cap during transport by the pipettor robot.
March 9, 2022da Vinci Xi and X 12-8 mm Conductive Cannula Reducer…Class IIConductive Cannula Reducer metal tip may get dislodged from the plastic shaft. If unnoticed, additional surgery may be required to remove the metal… Recall began Dec. 23, 2021
March 9, 2022Microbiologics QC Sets and Panels: Helix Elite… and 4 more productsClass IIReal-time shelf life testing failed at 24 months Recall began June 6, 2017
March 9, 2022AU/DxC AU Magnesium…Class IILipemic interference for the Magnesium serum application failed to meet the performance claim as defined in the IFU. Use may cause a maximum positive… Recall began Dec. 8, 2021
March 9, 2022Acorn 130 Stairlift…Class IIThe design of the seats did not consistently have the adequate strength required to support the customers weight with continued use. Recall began April 20, 2016
March 2, 2022IPELA FHD PTZ TILE KITS with Axis cameras used in combination with Natus Neuroworks/Sleepworks softwareClass IITile kits that allow one to install and situate a video camera within a patient environment are not fitting properly in some domestic institution… Recall began Dec. 2, 2021
March 2, 2022Endurant…Class IIStent Graft Systems built with specific batches of taper tip assemblies have the potential for the taper tip to detach from the delivery system.… Recall began Dec. 21, 2021
Feb. 23, 2022bellavista 1000 ventilator…Class IPotential cessation in ventilation can occur under specific conditions. Recall began Dec. 20, 2021
Feb. 2, 2022GE Vscan Extend… and 6 more productsClass IIThe firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to… Recall began Nov. 4, 2021
Jan. 26, 2022ZOCALO AJI LIMO DRIED CHILI PODS- ORGANIC…Class IIDue to presence of mold on product Recall began Dec. 13, 2021
Jan. 26, 2022VITROS Immunodiagnostic Products High Sample Diluent A Reagent PackClass IILower than expected results for VITROS Immunodiagnostic Products TSH Reagent Pack when diluted with VITROS Immunodiagnostic Products High Sample… Recall began Nov. 22, 2021
Jan. 19, 2022Top Quality Dog Food… and 1 more productClass ITop Quality Dog Food, LLC. 3630 East St. Hyattsville, MD 20785 has initiated a recall of Top Quality Dog Food, Beef HVM, 1 lb. pkgs in film casings… Recall began Aug. 19, 2021
Jan. 12, 2022Alinity m System…Class IIThere is an issue with the installation of updated camera firmware on the system. Recall began Dec. 6, 2021
Jan. 12, 2022Simplexa Direct Amplification Disc Kit…Class IIA subset of affected discs are at risk of leakage when it is used more than one time with Simplexa COVID-19 Direct and/or Simplexa Flu A/B & RSV… Recall began Nov. 19, 2021
Jan. 12, 2022QIAstat-Dx Respiratory SARS-CoV-2 Panel (US IVD under FDA EUA 200075)…Class IIThe firm identified sixteen (16) faulty cartridges in LOT 210209, which contain incorrect primer-probe mixes in the reaction chambers. If an affected… Recall began Nov. 8, 2021
Jan. 5, 2022Karl Storz Udel Sterilization Tray Instructions for Use…Class IITo ensure sterilization effectiveness, sterilization tray instructions for use were updated and now state 1) udel trays may be used with flexible… Recall began Oct. 15, 2021
Dec. 29, 2021Philips Allura Xper FD series with Software Version Number: 2.1.x- intended for Vascular…Class IISet screws securing the two gliding rods of the Extra Monitors (called 7th and 8th monitor) mounted on the Monitor Ceiling Suspension (MCS) can come… Recall began Nov. 19, 2021
Dec. 29, 2021Leica Microsystems M220 F12 Microscope SystemsClass IIIn May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury… Recall began Nov. 3, 2021
Dec. 29, 2021WIRION EMBOLIC PROTECTION SYSTEM…Class IUnder certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be… Recall began Nov. 22, 2021
Dec. 29, 2021Stealthstation System w/ Stealthstation Cranial Software 3.1.1,3.1.2,3.1…Class ICranial biopsy procedure software can enter a state where the biopsy depth gauge is no longer synchronized with the rest of the navigational… Recall began Nov. 11, 2021
Dec. 22, 2021Box Label: activ5 TINY GYM IN YOUR POCKET activbody Model: Activ5… and 1 more productClass IIDue to: 1) Manufacturing issue that result in inaccurate force measurement which may lead to may potential lead to incorrect treatment planning. 2)…
Dec. 22, 2021Miami J Select Collar…Class IIInstructions for use were updated to include additional information to facilitate the selection and use of the collar device. Recall began Nov. 9, 2021
Dec. 22, 2021MENTOR Saline-Filled Breast Implants are constructed from room temperature vulcanized silicone elastomer…Class IIDue to a manufacturing issue, Implant may have a potentially weakened area on the base patch portion of the implant which may cause leakage/deflation… Recall began Sept. 30, 2021
Dec. 15, 2021Trader Joe's Organic Blue Corn Tortilla Chips: 16 oz…Class IIPopcorn containing butter (milk) was found co-mingled with Trader Joe's Organic Blue Corn Tortilla Chips - undeclared milk allergen.
Dec. 8, 2021"Herbal Doctor" brand Angelicae Sinensis…Class IIProduct contains elevated levels of lead and cadmium Recall began Nov. 2, 2021
Dec. 8, 2021Tastykake Buttercreme Iced Creme Filled Chocolate Cupcakes 14.25oz… and 5 more productsClass IIThe firm was notified by an ingredient supplier of the potential small metal fragments in one of the ingredients. Recall began Oct. 31, 2021
Dec. 8, 2021NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product…Class IIThe Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2)… Recall began Oct. 29, 2021
Dec. 8, 2021The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood…Class IIDue to an uptick of complaints associated with premature needle retraction of blood collection system. Recall began Nov. 2, 2021
Dec. 8, 2021BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture…Class IIDue to an increased risk of false positive Acinetobacter calcoaceticus- baumannii complex results. The cause may be as a due to non-viable… Recall began Oct. 11, 2021
Dec. 8, 2021SHIP KIT…Class IIITop label of the outer package of the collection kit Item 5820-3118 showed expiration date of 2022/05/01 (correct expiration date) while side label… Recall began Oct. 14, 2021
Dec. 8, 2021Abbott HeartMate Touch Communication System…Class IIIf LVAS communication system is trying to establish Bluetooth connection and another Bluetooth-enabled device is nearby and advertising for Bluetooth… Recall began Oct. 22, 2021
Dec. 1, 2021Kings Hawaiian Hawaiian Sweet Hamburger Buns8 buns…Class IIProducts that were on HOLD for potential foreign materials was accidently released into commerce. The products released may be contaminated with…
Dec. 1, 2021ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87… and 1 more productClass IITwelve software-related issues affecting software version 9.41 and earlier were identified. The issues include bypassing error codes, incorrect… Recall began Sept. 29, 2021
Nov. 17, 2021Estradiol Valerate 20 mg/mL in Ethyl Oleate Inj… and 129 more productsClass IILack of assurance of sterility Recall began Oct. 12, 2021
Nov. 10, 2021Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit)… and 1 more productClass IIData provided in the Emergency Use Authorization (EUA) submission was insufficient to determine that the assays were adequately validated for the… Recall began Sept. 22, 2021
Nov. 10, 2021IPL Coupling Gel…Class IUltrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a…
Nov. 10, 2021FIVE S 3.5x65…Class IIDuring a regular requalification review, affected flexible intubation video endoscopes did not achieve the required sterility assurance level. There… Recall began Sept. 10, 2021
Nov. 3, 2021Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series…Class IIThe values of the Internal Standard (IS) concentrations are incorrectly derived when the user builds a customized test, then set the IS column to… Recall began Oct. 4, 2021
Nov. 3, 2021REF/Catalogue Number GSX0030A… and 8 more productsClass IISeptal Occluders contain the incorrect expiration date. Product is labeled with a 3 yr. expiration date instead of 2 yrs. Recall began Sept. 2, 2021
Oct. 27, 2021Roasted Lightly Salted Cashew Halves and Pieces… and 10 more productsClass IIA customer notified the firm that the product contained glass pieces. Recall began Sept. 24, 2021
Oct. 27, 2021VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)- For use in monitoring the…Class IIVITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls Outside of Expected Control Range, potential for delayed results Recall began Sept. 10, 2021
Oct. 20, 2021Elekta Medical Linear Accelerator (EMLA)…Class IIThere is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube… Recall began Sept. 17, 2021
Oct. 20, 2021Ion Flexison Biopsy Needle…Class IIPotential for the sheath tip on the biopsy needle to separate from the sheath shaft. Recall began Aug. 6, 2021
Oct. 13, 2021CardioQuip… and 3 more productsClass IILabeling does not include guidance for proper water-quality maintenance and device inspection for heater cooler devices. Recall began May 12, 2021
Oct. 13, 2021Access hsTnI High Sensitivity Troponin I…Class IIThrough customer feedback, testing a sample with cardiac troponin I concentration that are >270,000 pg/mL may cause carryover into the hsTnl reagent… Recall began Aug. 9, 2021
Oct. 13, 2021Nutrifill Scleral…Class IIContact lens solution may contain foreign material Recall began July 27, 2021
Oct. 13, 2021GEL CONDUCTOR… and 1 more productClass IUltrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a… Recall began Sept. 7, 2021
Sept. 29, 2021DLP Left Heart Vent Catheters… and 1 more productClass IIPotential for a wire protrusion through the left heart vent catheter tip Recall began Aug. 24, 2021
Sept. 29, 2021Ad-Tech Lightweight CABRIO Cable… and 2 more productsClass IIIncorrect version of labels were used. Recall began Aug. 9, 2021
Sept. 29, 2021EPIQ Diagnostic Ultrasound Systems: Software Versions 5.0… and 1 more productClass IIDue to a software defect that can intermittently cause the system to lock-up which exiting Review Mode while performing an exam. Recall began Aug. 6, 2021
Sept. 22, 2021BD Extension Set SMALLBORE Tubing with 2 SmartSite VALVES… and 14 more productsClass IINeedle-free connector valves, either standalone or attached to extension sets, may have issues including difficulty to flush, flow issues, and… Recall began Aug. 2, 2021
Sept. 15, 2021Nihon Kohden NKV-550 Ventilator…Class IIPotential defective gas inlet pressure regulator within ventilator which could result in gas releasing noise from the bottom of the ventilator, a… Recall began July 20, 2021
Sept. 15, 2021Pipeline Flex Embolization Device and 1 more productClass IDue to potential push wire fractures in the delivery system during use. The issue presents as a fracture in the spiral cut area of the Hypotube. Recall began July 13, 2021
Sept. 1, 2021Wegmans Sunflower Crunch Chopped Salad Kit: Includes Green Cabbage…Class IIUndeclared allergens in salad mix - milk and wheat. Cheese and croutons are packed separately and clearly visible to consumer.
Sept. 1, 2021AQUABEAM Handpiece…Class IIScope tube tip may detach from the telescoping tube, which is attached to a single-use handpiece, a component of an aquablation robotic system. Both… Recall began July 9, 2021
Sept. 1, 2021Monoject 0.9% Sodium Chloride Flush Syringe… and 2 more productsClass IPotential for the plunger to draw back after the air has been expelled and reintroduce air back into the syringe.
Aug. 25, 2021Cell Marque Antibodies…Class IIIMouse Monoclonal Antibody labelled with an incorrect expiry date of 31 Dec 2023. The correct expiry date is 31 Dec 2022. If used beyond expiry, the… Recall began July 15, 2021
Aug. 25, 2021EPIQ Ultrasound Systems…Class IIUltrasound system control panel arm swivel lock could fail, which could cause the control panel and monitor to swivel freely while a user is… Recall began July 22, 2021
Aug. 25, 2021Gore Propaten Vascular Graft configured for Pediatric Shunt… and 1 more productClass IIVascular Grafts containing an inner diameter of 6 mm may be incorrectly labeled as 5 mm and Vascular Grafts containing an inner diameter of 5 mm are… Recall began May 12, 2021
Aug. 18, 2021Monfefo brand Turmeric Shot…Class IIProduct was not manufactured according to specifications.
Aug. 18, 2021TJM6008 Jamshidi" Crown Bone Marrow Biopsy/Aspiration Needle with… and 2 more productsClass IIDue to complaints received regarding incomplete/open packaging seals potentially causing product to non-sterile. Recall began June 23, 2021
Aug. 18, 2021Medtronic StimLoc Burr Hole Cover…Class IIExcess nylon flash on the clip. Recall began June 2, 2021
Aug. 18, 2021Chassis Label…Class IIDue to failure to acquire pre-market clearance for its high resolution tomographic/biomicroscope imaging device (Model 6000) prior to commercializing… Recall began July 8, 2021
Aug. 11, 2021GlideScope Go MonitorsClass IIIHandheld video monitor failed to meet the labeled IP67 rating which may allow fluid ingress into the monitor resulting in loss of functionality. Recall began July 1, 2021
Aug. 4, 2021OEC 3D Imaging… and 1 more productClass IIThere is a potential that the coin cell battery used to monitor X-Ray tube temperature may deplete early causing the system to become inoperable. Recall began June 10, 2021
Aug. 4, 2021ThermoScientific Oxoid Antimicrobial Susceptibility Discs Rx only Made in the United KingdomClass IIOut of Specification Recall began June 18, 2021
July 28, 2021Infant Heel Warmer with Attachment Tab… and 1 more productClass IIA caution statement is being added to remind the user to activate away from face and infant as reports of pack rupture or leaking during activation… Recall began June 9, 2021
July 28, 2021Cotton Rounds/Pads under the following brand names: 1…Class IIPotential for mold contamination (Aspergillus vadensis) Recall began May 25, 2021
July 21, 2021NomNom Cat Chicken Cuisine 50gm…Class IDownstream Recall. Potential L. mono contamination due to ingredient used.
July 21, 2021Medtronic LINQ II Model Number # LNQ22 Insertable Cardiac Monitor Sterile EO Rx OnlyClass IIDevice fail to detect Brady episodes, Pause (Asystole) episodes and PVC's after a ride-through POR reset. Recall began May 14, 2021
July 21, 2021Lingen Disposable Virus Sampling Kit… and 1 more productClass IINo 510(k) clearance Recall began June 10, 2021
July 21, 2021Toshiba Vantage Tiitan 1.5T with Standard gradient… and 3 more productsClass IIThe MRI system contains a component that does not meet the appropriate flame retardancy-rating which could result in smoke or fire. Recall began May 21, 2021
July 14, 2021CoreValve Evolut R Delivery Catheter System… and 2 more productsClass IIDue to reports of actuator separation for various delivery catheter systems. Affected products were manufactured before July 11, 2020. Recall began June 11, 2021
July 14, 2021FilmArray Pneumonia Panel (Pneumo) Part Numbers: Part No… and 1 more productClass IIDue to real-time stability study failures resulting in increase rate of false negative results between the 6 to 12 month expiry time-frame. Recall began June 7, 2021
July 14, 2021FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems…Class IIThe high and low level "Quality Controls" demonstrate a positive bias of approximately 10% compared to assigned values. Recall began May 20, 2021
July 14, 2021Verigene Respiratory Pathogens Flex Nucleic Acid Test (RP Flex) Model… and 5 more productsClass IIPotential for a false-negative result. Recall began Oct. 30, 2020
July 7, 2021Edwards TruWave (3 cc)/VAMP Jr 48 in (120 cm) Kit… and 7 more productsClass IIThere is a potential that the pressure tubing may detach from the blood sampling system Recall began May 26, 2021
July 7, 2021Lyra SARS-CoV-2 Assay (M120) in vitro diagnostic test reagentClass IIn rare situations patients infected with high viral load of SARS CoV 2 may have samples that generate Ct values less than or equal to (d) 5 when… Recall began April 27, 2021

Showing the 600 most recent of 2,070 recalls.

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