Recalls distributed in Massachusetts

• Nov. 4, 2026ALPHENIX INTERVENTIONAL ANGIOGRAPHY SYSTEM REF: INFX-8000C and 2 more productsClass IIDue to software issue, X-ray interventional system may experience internal error if F-Store or imagine acquisition is performed while clinical…
• Nov. 4, 2026Orthoscan VERSA Accessory Cart…Class IIThe accessory cart weldment does not conform to weld dimensional specifications which may result in separation of the monitor arm mounting structure… Recall began Sept. 3, 2026
• Nov. 4, 2026OmniaSecure Model 3930M…Class IIAffected leads require additional engineering evaluation due to complaints regarding difficulty in achieving fixation during implantation. Potential… Recall began Sept. 17, 2026
• Oct. 28, 2026Trader Joe's Crispy Rice Milk Chocolate Bar…Class IIUndeclared wheat. Product outer label incorrect; contains wrong allergen ingredients. Recall began Sept. 3, 2026
• Oct. 28, 2026GEARHARTS FINE CHOCOLATES…Class IIForeign Object - Broken glass was found in a piece of finished product. Recall began Sept. 22, 2026
• Oct. 28, 2026Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS)…Class IIA software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier… Recall began Sept. 2, 2026
• Oct. 28, 2026Ion Torrent Genexus Dx with software…Class IIDNA or RNA sequencing system software has vulnerabilities. Recall began Aug. 14, 2026
• Oct. 28, 2026Techno-Path Multichem AE Unassayed Level 1 REF:AE621X and 2 more productsClass IIA routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control… Recall began Aug. 14, 2026
• Oct. 28, 2026PNE Lead Implant Kit REF: 1701Class IIRetroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users. Recall began July 15, 2024
• Oct. 28, 2026Medtronic NDI Passive Spheres REF: 8801071… and 3 more productsClass IISterile Passive spheres and biopsy needle kits contain variation in the reflective material which may affect the ability of the navigation system to… Recall began Aug. 31, 2026
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• 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, 2026Deano's Pasta…Class IUndeclared Lobster
• 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, 2026LeadCare II Blood Lead Test Kit…Class IIIIn kit sub-lot 2530M-01 the date of expiration printed on the outer labeling may indicate the wrong expiration date of July 22, 2026 while the… Recall began Sept. 4, 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, 2026PERMA-HAND Silk Black Braided Sterile Nonabsorbable Surgical Suture…Class IISilk sutures, indicated for use in cardiovascular, ophthalmic and neurological procedures, packaged with alcohol-based fluid, not part of product… Recall began Sept. 8, 2026
• Oct. 21, 2026Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product…Class IIPotential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where… Recall began Sept. 14, 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. 21, 2026JenaValve Trilogy Delivery Catheter… and 2 more productsClass IIDelivery Catheter may have sleeve liner separation that results in difficulty or inability to deploy heart valve device. Recall began July 31, 2026
• Oct. 21, 2026HemoslL AcuStar HIT-lgG(PF-4)… and 1 more productClass IPotential for invalid calibration curve or negative mean bias of up to 47% with patient samples. Recall began Sept. 3, 2026
• Oct. 14, 2026SEDIPLAST…Class IIDuring use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause… Recall began Aug. 25, 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. 14, 2026Spectral CT and Spectral CT 7500 RT…Class IISoftware issues may affect the safety and performance of Spectral CT system(s). The issues may result in image artifacts, wrong slice thickness, or… Recall began Aug. 21, 2026
• Oct. 7, 2026Organiccs Absolutely Pure…Class IIUndeclared shellfish (crab shell): source of ingredient Glucosamine sulfate
• Oct. 7, 2026Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard… and 1 more productClass IIDue to blood-to-glycol leak in the heat exchanger. Recall began July 17, 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, 2026Computed Tomography X-ray System… and 11 more productsClass IIPositron emission tomography and computed tomography x-ray systems have a software problem when Split or Local function is enabled, and multiple RIS… Recall began Aug. 11, 2026
• Oct. 7, 2026Philips IntraSight Plus REF: 797423 and 797417 100-120v-220-240v,50/60hZ…Class IISoftware system may associate image data from one patient with another patient's record, potentially resulting in incorrect diagnosis or treatment. Recall began Aug. 6, 2026
• Oct. 7, 2026EnCor EnCompass Breast Biopsy and Tissue Removal System Console (model number: ENCPCONSOLE) and Driver (model…Class IIBreast biopsy and tissue removal system may experience the following errors: 1) Probe calibration and /or handheld driver failure (code… Recall began Aug. 20, 2026
• Oct. 7, 2026McKesson CONSULT hCG Urine Cassette… and 3 more productsClass IIhCG rapid tests may detect low levels of hCG below the stated assay sensitivity, which may result in false positive result. Recall began Aug. 20, 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
• Oct. 7, 2026VentStar Resus Neo…Class IPotential cracks in the hose, which could lead to leakage or the hose falling off. Recall began Sept. 3, 2026
• Oct. 7, 2026NovaSeq 6000Dx including DRAGEN Server…Class IIRetrospectively reported correction for an instrument intended for targeted sequencing of DNA libraries from human genomic DNA used with in vitro… Recall began Sept. 17, 2024
• Oct. 7, 2026Brand Name: Expressaire Product Name: DISPOSABLE TOURNIQUET CUFF… and 63 more productsClass IIDue to incorrect expiration date on product manufactured between September 2016 to March 2023. Products are labeled with a 10 year shelf life. The… Recall began Aug. 24, 2026
• Sept. 30, 2026Fromagerie Coop de Mean Cabricharme and Belgium Cabricharme Shelf life: 30 days…Class IUndeclared Egg Allergen
• Sept. 30, 2026nGenuity Patient Monitor with Capnography (ETCO2) CAT 8100E1-ST-US…Class IIComplaint trend where "Checkline Error" alarm presents at device setup, rendering the CO2 monitoring function inoperable. May result in procedure… Recall began May 6, 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. 30, 2026SeaSpine Mariner Deformity Product Name: Extended Polyaxial Head…Class IIThe proximal thread depth of the spinal device is out of design specification. Recall began Aug. 19, 2026
• Sept. 30, 2026Brand Name: Heidelberg Engineering GmbH Product Name: SPECTRALIS with Flex Module Model/Catalog Number: S3610…Class IIWheels may come loose when module is being pushed or pulled during movement or transportation, affecting stability of the stand. The stand may tip… Recall began Aug. 6, 2026
• Sept. 23, 2026Hexing Haw Balls candy…Class IIIUnapproved dye Ponceau 4R
• Sept. 23, 2026Diced Jalapenos… and 24 more productsClass IPotential contamination with Salmonella. Recall began Aug. 7, 2026
• Sept. 23, 2026Pi-Cardia Inc. ShortCut REF: Z-A-20.003-USClass IITransfemoral catheter, positing arm may detached due to weld issue. Recall began July 6, 2026
• Sept. 23, 2026Reign Medical Clench Staple System (Compression)…Class IIBone fixation staple requires a new 510(k); the performance characteristics of this device have not been adequately established. Recall began July 15, 2026
• Sept. 23, 2026Boston Scientific Corporation StoneSmart Connect Console Contents: (1) Power Cord…Class IIA subset of power adapters used with the connect console may exhibit higher-than-expected resistance in the electrical grounding path. As a result… Recall began July 22, 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
• Sept. 23, 2026EWO_02512 (Catalog number 320550) For Investigational Use Only Nano… and 1 more productClass IIRetrospectively reported: Pen needles labeled 'For Investigational Use Only' were inadvertently distributed as commercially marketed devices. Recall began July 26, 2023
• 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, 2026GM Helix Implant…Class IIThere is a discrepancy between the product identification on the packaging and the dimensions of the implant contained inside. Recall began Aug. 12, 2026
• Sept. 23, 2026Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002…Class IIDue to a software issue Recall began Oct. 22, 2025
• 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, 2026Alfalfa…Class IPotential E. coli and Salmonella contamination
• 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. 16, 2026Products that contain the Pericare Wipes: Bardex Lubricath Foley… and 5 more productsClass IIDue to complaints received indicating presence of contamination on the surface of pericare wipes provided with various Foley and Intermittent… Recall began June 25, 2026
• Sept. 9, 2026El Eden Import Distributor Corp Recalls Ineligible Pork Cracklings Products Imported from The Republic of…Class IImport Violation
• Sept. 9, 2026Brand Name: Extension Set Product Name: DISCOFIX FOUR WAY STOPCOCK Model/Catalog Number: 456025Class IISpecific lots of Discofix Stopcock Sets recalled due to an incorrect expiration date printed on the carton shipper label. Recall began Aug. 4, 2026
• Sept. 9, 20265008X Standard HD Pre-Flush Standard Blood Tubing Set Part Number… and 3 more productsClass IIHeightened probability of blood leak from the connection between the Arterial Alpha Clip and the main line or pump segment. Leak during treatment may… Recall began Aug. 10, 2026
• Sept. 9, 2026Baxter Novum IQ Syringe Pump… and 1 more productClass IIA software issue that may occur during a Volume/Time (VOT) multi-syringe infusion when a syringe reaches empty and is replaced while a Volume To Be…
• Sept. 9, 2026HEALON EndoCoat PRO…Class IISurgical instructions sent for viscoelastic products used during ophthalmic viscosurgical cataract procedures including in part: If resistance is… Recall began July 31, 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, 2026Outshine Fruit Bars Strawberry… and 5 more productsClass IIForeign object: products may contain glass pieces
• Sept. 2, 2026Medline convenience kits labeled as: 1) FEMORAL PACK… and 10 more productsClass IIKits contain a potentially contaminated component which were recalled by the manufacturer Recall began July 10, 2026
• Sept. 2, 2026Medline medical convenience kits… and 3 more productsClass IISpecific item(s) and lot(s) of Medline convenience kits containing Pilling Wecksorb Neurosponges and Neurosponge Strips are being recalled due to… Recall began July 8, 2026
• Aug. 26, 2026Shanghai Ravioli Corporation Recalls Not Ready-To-Eat Frozen Buffalo Chicken Products Produced Without the…Class IProduced Without Benefit of Inspection
• Aug. 26, 2026Gifford's HomeMaine ice cream brand POWER PLAY FUDGE…Class IIPotential foreign object contamination: rubber pieces
• 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, 2026Protein Cereal Cocoa Crunch…Class IISoy not declared in the contains statement.
• 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, 2026Dentsply Sirona Capsule Mixer Model No…Class IIPotential for electrical discharge from unit when unplugged. Recall began July 20, 2026
• Aug. 26, 2026Hamilton Microlab STAR Liquid Handler…Class IISoftware issue that can cause an increase in spontaneous software closures. Recall began June 10, 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. 26, 2026BD Needle Kit for Powered Driver 15mm x 15Ga…Class IAfter placement of intraosseous (IO) needle sets, used when intravenous access is difficult or impossible to obtain in emergent, urgent, or medically…
• Aug. 19, 2026Cross Valley Farms LETTUCE CHOP 4/5# Cross Valley Farms LETTUCE SHRED… and 20 more productsClass IPotential Cyclospora contamination. Recall began July 17, 2026
• Aug. 19, 2026Aquafaba Powder…Class IUndeclared Egg
• 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. 19, 2026OBP Medical…Class IIThere is a potential for vaginal speculums to contain a burr on the proximal plastic blade, which may introduce a sharp edge in the contact regions… Recall began July 13, 2026
• Aug. 19, 2026GM Helix Implant…Class IIThere may be a mismatch between the implant contained inside the packaging and the information described on the outer carton label. If the the… Recall began July 13, 2026
• Aug. 19, 2026Brand Name: Xhibit Product Name: Xhibit Central Station Model/Catalog Number: 96102 Software Version: N/A…Class IIDue to off-the-shelf display port component that has audio/video failures Recall began June 4, 2026
• Aug. 19, 2026navify Digital Pathology (on-prem) v2.5…Class IIDue to complaints received for the Image Management System regarding image/metadata discrepancy with the Viewer window Recall began April 20, 2026
• Aug. 12, 2026REF # D23352… and 1 more productClass IIAnalyzers contain incorrect algorithms which may affect antimicrobial susceptibility test results, leading to false susceptibility classifications." Recall began June 26, 2026
• Aug. 12, 2026HardyDisk AST Cefiderocol 30g (FDC30) REF Z9435 HardyDisk AST Cefiderocol 30g (FDC30) for in vitro agar…Class IIDue to incorrect cartridges include in affected products that there is the potential for false-susceptible or false-resistant susceptibility results… Recall began June 8, 2026
• Aug. 12, 2026Syva Emit tox Serum Tricyclic Antidepressant Calibrator/Controls SMN 10445390 Catalog No…Class IIIout-of-specification sodium azide concentration in Syva Emit Tox Serum Tricyclic Antidepressant Calibrator/Controls Lot U2. While the assay results… 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. 12, 2026Radial Jaw 4 Standard Capacity Biopsy Forceps with the following… and 2 more productsClass IIPotential for breach in sterile barrier of device packaging. Recall began June 30, 2026
• Aug. 5, 2026Sainforage Sainfoin + Grass + Alfalfa Forage Pellet 40 lb (18.14 KG)… and 2 more productsClass IElevated aflatoxin levels
• Aug. 5, 2026Stryker Hoffmann II Connecting Rod Micro 3 x 30mm… and 6 more productsClass IIPotential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization. Recall began July 1, 2026
• Aug. 5, 2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as… and 7 more productsClass IIWindstone Medical Packaging recalled specific items and lots of AMS convenience kits containing Elevaris Lidocaine HCl injection USP. Elevaris… Recall began June 17, 2026
• Aug. 5, 2026L-Cath PICC S/L Peripherally Inserted Central Catheter: 26ga (1.9F)… and 1 more productClass IICatheters, indicated for short/long-term peripheral access to central venous system for the administration of fluids, medications, nutrients; and… Recall began June 15, 2026
• Aug. 5, 2026AMS ALIGNED MEDICAL SOLUTIONS medical convenience kits labeled as: 1)… and 3 more productsClass IIThe recall notice was initiated due to a Medicom Urgent Medical Device Recall. Medicom is recalling specific lots of Ritmed Neurological Sponges… Recall began June 8, 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, 2026Flexible Hystero-Fiberscope Kits REF: 11264BBU1…Class IIFlexible hysteroscopes indicated for use during diagnostic and operative hysteroscopic procedures may contain an expired single use endoscopic seal… Recall began May 21, 2026
• July 29, 2026Medline medical convenience kits labeled as: 1) KIT PEDIATRIC OPEN… and 3 more productsClass IIMedline Industries, LP is issuing a recall for specific Medline convenience kits containing BD PurPrep 26 mL which may be contaminated with low… Recall began June 11, 2026
• July 29, 2026MiniMed Go App…Class IIFor MiniMed Go app version 1.0.0 and 1.1.0, when the Set day and night is turned OFF and missed dose or Correct high glucose alerts are enabled, the… Recall began June 16, 2026
• July 29, 2026Pipeline Flex Embolization Device with Shield Technology… and 1 more productClass IIIncorrect labeling - embolization devices labeled as 3.0 mm x 20 mm implants contain 12 mm implants, and devices labeled as 3.0 mm x 12 mm implants… Recall began June 8, 2026
• July 29, 2026Boston Scientific TheraSphere 360 Y-90 Management Platform…Class IISoftware anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more… Recall began June 19, 2026
• July 29, 2026Penumbra System RED 68 Reperfusion Catheter REF: RED68KITClass IIDue to manufacturing issues, reperfusion catheters may fractures Recall began June 3, 2026
• 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 22, 2026da Vinci SP Instrument Arm Drape…Class IIRobotic-assisted surgical system arm drapes may detach from the instrument arm due to an issue involving the drape rings located at the top of the… Recall began May 12, 2025
• July 22, 2026Abiomed REF: 0052-3025… and 2 more productsClass IDue to manufacturing issues, there is a potential for the 14Fr and 23Fr introducer sheaths to leak from the sidearm, under the sheath cap, and along… Recall began June 10, 2026
• July 15, 2026GSP Neonatal GALT Kit…Class IIReduction in the on-board stability of the GSP GALT assay. This may increase the likelihood of run-QC failures and consequently delay the reporting… Recall began May 18, 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, 2026MorningStar Farms Buffalo Chik'n Nuggets… and 1 more productClass IIPotential contamination with plastic material
• 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, 2026Radius VSM ECG pre-connected Set… and 1 more productClass IITwo devices recalled: 1) Electrocardiogram (ECG) electrode assembly ECG feature may incorrectly detect extreme bradycardia, tachycardia and trigger… Recall began Feb. 20, 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 8, 2026Brand Name: Pilling Wecksorb Product Name: Pilling Wecksorb Neurosponges (Cotton) Pilling Wecksorb…Class IIDue to out-of-specification, or potential out-of-specification, levels of endotoxins Recall began May 7, 2026
• July 8, 2026IntelliCuff…Class IIDue to reported complaints, the cuff device may alarm with a "Cuff System Leakage" error. As a result, the motor may pump continuously and fail to… Recall began May 22, 2026
• July 1, 20261.5oz Zapp's Bayou Blackened Ranch Kettle Chips… and 5 more productsClass IPotential presence of Salmonella. Recall began April 28, 2026
• July 1, 2026Total Parental Nutrition…Class IIIncorrect product formulation: bag did not contain copper and famotidine per label.
• July 1, 2026Convenience kits containing select SKUs of 10mL Polycarbonate Colored… and 15 more productsClass IIFirm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601. Recall began Feb. 27, 2026
• July 1, 2026Philips Telemetry Monitor 5500 1.4 GHz…Class IIPotential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a…
• July 1, 2026Surgify Halo… and 18 more productsClass IIPotential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS). Recall began April 30, 2026
• July 1, 2026Thuvera Laser Console…Class IISoftware anomaly that causes a false display of error code 5018. Recall began May 5, 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
• July 1, 2026Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw…Class IIDue to manufacturing error, hexalobe screws used with wrist fixation system may break during use. Recall began May 28, 2026
• July 1, 2026TMJ Bilateral Implants…Class IICustom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a… Recall began Feb. 11, 2026
• July 1, 2026Da Vinci ASSY…Class IIOperative components of surgical systems potentially distributed with E-brake retainer pin, so in event of a structural column failure, the E-brake… Recall began April 22, 2026
• June 24, 20264411 (Beef… and 36 more productsClass IPotential Listeria monocytogenes contamination Recall began May 19, 2026
• June 24, 2026azuma foods TAKO WASABI Seasoned Octopus with Wasabi PERISHABLE/KEEP FROZEN PRODUCT OF JAPAN DISTRIBUTED BY…Class IUndeclared fish.
• 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, 2026Splashwire Hydrophilic Guide Wire: REF: MSWSTDA35150 UDI-DI codes: 00884450529645 00884450529669…Class IIDue to unsealed portions of pouches. Recall began May 8, 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, 2026Product Name: STAAR ICL Calculation Software Software Version: Version 8.00 Product Description: The STAAR…Class IIDue to a software coding issues for calculating the implant orientation diagram printout for the implantation for toric implantable collamer lenses. Recall began April 20, 2026
• 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, 2026directCHECK ACT-LR whole blood quality control…Class IIAssayed Whole blood control contains labeling with incorrect performance range. Recall began April 30, 2026
• 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: SPORETRAQ MAIL-IN SPORE TESTING SERVICE… and 1 more productClass IIDue to incorrect incubation process being performed on product. Recall began April 13, 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 17, 2026EXCOR Pediatric Ventricular Assist Device (VAD) System Blood Pump PU Valves: 10 ml…Class IIBlood pump inner package expiration date does not match the outer-correct expiration date, which may lead to delays in surgical procedures. Recall began April 24, 2026
• June 17, 2026Plum Solo Precision IV Pump… and 2 more productsClass IIUnder certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming… Recall began April 29, 2026
• June 10, 20261) Cheese Sauce Mix… and 3 more productsClass IProduct contains dry milk powder ingredient recalled by the supplier due to potential Salmonella contamination Recall began May 6, 2026
• June 10, 2026Hellas Meze Golden Smoked Whole HerringClass IUn-eviscerated fish may be contaminated with clostridium botulinum
• 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
• June 10, 2026Avanta Multi-Patient Administration Tube Sets (AVA 500 MPAT (Part 2 of 2)) used with the Medrad Avanta…Class IISupplier changes resulted in a fit issue with the Contrast Flow Control Valve (CFCV) interface on the Avanta Injector System. Multiple customer… Recall began April 24, 2026
• June 10, 2026Digital Angiography System Trinias:UD150G-40 / D150GC-40…Class IIElectromagnetic contactors within high voltage generator may weld together, resulting in current being supplied to power supply even if power is off. Recall began April 20, 2026
• June 10, 2026Arvis Hip & Knee 3.0 Instrument Set… and 1 more productClass IIThe V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face. Recall began April 23, 2026
• June 10, 2026Brand Name: HiResolution" Bionic Ear System Product Name: HiRes Ultra 3D CI HiFocus Mid Scala Model/Catalog…Class IIDue to incorrect shelf-life expiration date. Recall began April 30, 2026
• June 10, 2026The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS)…Class IIPotential for the Cassette Loading Lever to break. Recall began Feb. 4, 2026
• June 10, 2026Covidien Mon-a-Therm Esophageal Stethoscope with Temperature Sensor… and 2 more productsClass IITemperature probe devices lack FDA clearance. Recall began April 23, 2026
• June 10, 2026Brand Name: Exacta Mix Product Name: Vented Micro-Volume Inlet Model/Catalog Number: H938175 Product…Class IIAffected lots may contain incorrect 0.8-micron filters. Use of a 0.8-micron filter in place of the validated 3-micron filter may lead to reduced flow… Recall began April 22, 2026
• June 10, 2026BDSpinal Tray with BDQuincke Needle 22 G x 3.5 in… and 9 more productsClass IThis is a sub-recall of a product recall from Huons Co, Ltd., the manufacturer of Bupivacaine Hydrochloride in Dextrose Injection, USP. The recall is… Recall began April 27, 2026
• June 10, 2026Atlan A350… and 1 more productClass IThe Atlan anesthesia workstation either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation… Recall began May 7, 2026
• June 3, 2026Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS)…Class IINitrile Exam Glove failed to meet specifications chemical permeation performance. Recall began April 13, 2026
• June 3, 2026Automated Impella Controller (AIC)…Class IA retrospective review identified that there are AIC units requiring specific hardware updates to address potential safety concerns. These hardware… Recall began April 20, 2026
• May 27, 2026Albright's All Natural Raw Pet Food Chicken Recipe for Dogs Compete and Balanced Net Weight 1 LB (456G)…Class IPotential Salmonella contamination
• May 27, 2026Vitamin B-Complex…Class IIForeign object: black particulate matter
• May 27, 2026Silastic Foley Catheters Silastic Brand Foley Catheter 30cc REF: 33416 33418 33420 33422 33424 Silastic Brand…Class IIDue to stain present on the surface of affected foley catheters. Recall began April 23, 2026
• May 27, 2026Oncology Kit w/60" (152 cm) Appx 2.2 ml…Class IIOncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if… Recall began March 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, 2026Swad Orange Flavored Masala Candy and 1 more productClass IIContains undeclared FD&C Yellow 6 Recall began April 13, 2026
• May 20, 2026Alain MILLIAT…Class IIProduct may contain foreign objects, specifically glass. Recall began March 26, 2026
• May 20, 2026Edwards EVOQUE tricuspid delivery system REF:9850TDS Sterile EOClass IILabeling update to provide warning if functionality of the valve replacement delivery system is compromised. Recall began March 27, 2026
• May 20, 2026QuickVue Dipstick Strep A Test…Class IIProduct has the potential for false positive results Recall began April 6, 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, 2026LUCAS 2 Model Number: 99576 Catalog Numbers: 99576-000024 and 99576-000011 UDI-DI code: 00883873904565 LUCAS…Class IIDue to a subset of chest compression systems/devices where the service performed on the systems were not appropriately documented (The documents for… Recall began April 13, 2026
• May 20, 2026Brand Name: DONJOY Product Name: ICEMAN CLASSIC CUBE Model/Catalog… and 3 more productsClass IIDue to broken connector which may result in a temporary interruption of prescribed cold therapy. Recall began March 19, 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, 2026LIFEPAK 15…Class IISome defibrillators serviced between July 2023 through November 2025 were serviced without objective evidence that a Performance Inspection Procedure… Recall began April 13, 2026
• 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, 2026Negita Cracker- Shrimp 2.8ozClass IIContains undeclared FD&C Yellow 6
• 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: HiResolution" Bionic Ear System Product Name: M Zn-Air Battery Pak Model/Catalog Number…Class IIThe non-tamperproof battery door supplied with the sound processor fails to conform to IEC 60601-1-11:2015 by not requiring the use of a tool to… Recall began March 23, 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, 2026Spice Powder…Class IILead level was higher than NYSAGM Standard. Recall began Oct. 17, 2024
• April 29, 2026Protocol Configuration Tool (PCT) software v1.3.0 for Hamilton AutoLys STAR used within FoundationOneCDx…Class IIPotential for spontaneous closures of Hamilton HxRunControl software during execution of Autolys protocols after deployment of the PCT software for… Recall began March 24, 2026
• April 29, 2026Sequencing Agent SEQ0067…Class IIPossible increase in phasing, potentially resulting in false-positive BARD1 splice site indel artifact variants Recall began March 20, 2026
• April 29, 2026Flamingo Funnel Small… and 2 more productsClass IICertain lots of product were associated with a manufacturing nonconformance involving use of a non-gamma sterilization compatible drape. Recall began March 16, 2026
• April 29, 2026Arrow Echogenic Introducer Needle REF ASK-04001-BWK2 UDI code… and 7 more productsClass IIDue to receiving a notice from a supplier that the liquid adhesive were incorrectly manufactured Recall began March 11, 2026
• April 22, 2026Gentuity HF-OCT Imaging System Model G10-01…Class IIThe potential for repeated frames during HF-OCT pullback when using the Gentuity HF-OCT Console (software version 21.11 to 23.3.13) with the Vis-Rx… Recall began March 23, 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, 2026Vital Nutrients Aller-C (vitamin C…Class IIContains undeclared egg, soy, and hazelnut
• April 15, 2026Riverence Smoked Trout Dip…Class IILabel declares cream cheese but does not declare milk
• 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 15, 2026Tornier HRS Max parts: 1…Class IIAffected products were incorrectly labeled as Tornier HRS Max products. These parts are compatible with the Tornier HRS system only, and are… Recall began March 5, 2026
• April 8, 2026Imu-Tek Colostrum-5 120 Capsules… and 1 more productClass IIProduct is potentially under-processed. Recall began Feb. 24, 2026
• April 8, 2026Coconut Drink 1…Class IIProduct contains undeclared milk.
• April 8, 2026MEI HEONG YUEN TANGERINE FLAVOR ROASTED PEANUTS… and 2 more productsClass IIIProducts contain cyclamates (banned sweetener) Recall began Feb. 19, 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, 2026POPPING BOBA RTD PEACH OOLONG TEA 12 X 13.8OZ and 3 more productsClass IIIPackaging integrity issue that may compromise product quality .
• April 8, 2026SIGNA Premier systemsClass IIWhole-Body MR scanners used to produce images of the inside of the human body to aid diagnosis of disease may have been manufactured/serviced with… Recall began Feb. 27, 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 8, 2026Airway Exam Kit… and 6 more productsClass IIKits contain recalled Olympus biopsy valves. Olympus is investigating an increase in complaints associated with rubber fragment detachment in the… Recall began Feb. 16, 2026
• April 8, 2026Brand Name: da Vinci S… and 1 more productClass IIDue to increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments Recall began Dec. 9, 2025
• April 8, 2026Brand Name: da Vinci S… and 3 more productsClass IIDue to increased complaints for broken/frayed grip cables for reusable instruments. Recall began Dec. 9, 2025
• April 8, 2026Jiffy Original Composite Polisher Cups (Coarse) 12pk…Class IIComposite polisher cups may crumble and break apart easily, which could cause a delay in patient treatment. Recall began Jan. 28, 2026
• April 1, 2026SAVANNAH BEE COMPANY HONEY BBQ SAUCE MUSTARD NET 16 FL OZ (453g)…Class IIUndeclared Allergens: Soy & Wheat. The firm was notified by a customer that the product is labeled as Savannah Bee Company Honey BBQ Sauce "Mustard"… Recall began Feb. 27, 2026
• April 1, 2026Item 5650173 Trader Joe's Japanese Style Fried Rice with Edamame… and 10 more productsClass IIForeign objects are glass varying in size from 1-3cm long and 2-4mm wide.
• 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, 2026Brand Name: BiDop 3 Product Name: BiDop 3 Pocket Doppler (ES-100V3) with BT2M20S8C fetal probe Model/Catalog…Class IIProduct labeling includes a fetal indication for use that is not cleared under its 510(k).
• April 1, 2026MicroScan Neg MIC 56 REF C42464 UDI-DI code: 15099590731212 MicroScan panels are designed for use in…Class IIDue to the likely presence of contamination in well(s). Recall began July 24, 2025
• April 1, 2026Volar Radius Plate with Angular Stability with the following… and 16 more productsClass IIUpdated MRI safety testing demonstrates higher RF-induced temperature increases under certain MRI conditions than previously reflected in the… Recall began Jan. 23, 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, 2026Dog Food… and 4 more productsClass IProduct tested positive for positive for one or more types of pathogenic (harmful) bacteria, specifically: Listeria monocytogenes, Salmonella… Recall began Jan. 26, 2026
• March 25, 2026Multivitamin with Fluoride Chewable Tablets Grape Flavor Rx NDC 75826-169-10 0.25 mg 100 TABLETS…Class IIISubpotent. During an FDA inspection it was discovered that the product was subpotent for Vitamin D. Recall began Oct. 27, 2025
• March 25, 2026Brand Name: Leksell Gamma Knife Product Description: Leksell Gamma Knife Perfexion Leksell Gamma Knife Icon"…Class IIDue to adapter not being properly aligned or locked in place. Recall began Feb. 18, 2026
• March 25, 2026Brand Name: Welch Allyn…Class IIDisplay screen may unintentionally flicker due to a software issue. Exposure to flickering lights may induce photosensitive seizure activity in… Recall began Feb. 18, 2026
• March 23, 2026FSIS Issues Public Health Alert for Ground Beef Products Due to Possible Foreign Material ContaminationProduct Contamination
• March 18, 2026Artelon FlexBand Dynamic Matrix Ref: 31057 and 2 more productsClass IIAugmentation devices failed bacterial endotoxin testing. Recall began Feb. 6, 2026
• March 18, 2026PHYSIO CONTROL INFANT/CHILD Reduced Energy Defibrillator Electrodes Catalog Numbers: 11101-000016 UDI-DI…Class IIDue to pediatric defibrillator electrode delamination Recall began Jan. 21, 2026
• March 18, 2026Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle… and 1 more productClass IIImpactor handle may be missing cross-pin Recall began Feb. 3, 2026
• March 18, 2026Raz-AT (Attendant Tilt) Mobile Shower Commode Chair…Class IIDue to a modification by a vendor and may be reinstalled without properly engaging the outside rear seat brackets that are used to keep the seat in… Recall began Jan. 5, 2026
• 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 11, 2026Brand Name: AESCULAP Product Name: MINOP TROCAR 150MM 4 WKING CHANNEL6.0MM Model/Catalog Number: FF399R…Class IIThere is the potential for the length of the trocar shaft to be too long. Recall began Jan. 15, 2026
• March 4, 2026NAVITAS ORGANICS ORGANIC CHIA SEEDS…Class IPotential contamination with Salmonella. Recall began Jan. 23, 2026
• March 4, 2026Prime Food Processing Dried Croaker Fish…Class IUneviscerated Fish
• March 4, 2026PIE Trolley System Model: 2005 and 1 more productClass IILack of 510K clearance Recall began Jan. 14, 2026
• March 4, 2026Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP… and 2 more productsClass IIKnee and Humeral socket implants contain incorrect labeling. Recall began Jan. 15, 2026
• 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
• Feb. 25, 2026Pure Factors Professional Nighttime Sleep Formula and Pure Formulas Sleep Reset…Class IILabel declares bovine colostrum but does not declare milk allergen.
• Feb. 25, 2026Da Vinci 5 ASSY…Class IIAn error event following the release of a software version for the surgical system that can result in loss of user interface content on an external… Recall began Nov. 17, 2025
• 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, 2026CREAMY PEANUT BUTTER… and 2 more productsClass IIForeign material. During production, the firm found pieces of blue plastic in a filter. Recall began April 30, 2025
• Feb. 18, 2026a.) Preema brand Bright Red Food Colour Powder…Class IIProducts contain banned color, carmoisine and undeclared FD&C Yellow 5 and FD&C Red 40
• 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. 18, 2026ATEC Lateral Navigation Disc Prep Instruments LIF NAV… and 1 more productClass IIDue a design issue where the navigated array connection geometry is incorrect. Recall began Jan. 2, 2026
• Feb. 18, 2026Brand Name: Leksell GammaPlan Product Name: Radionuclide RT Treatment… and 1 more productClass IIDue to an error when defining a new stereotactic reference that users fail to first change an already defined obsolete reference to a pre-plan… Recall began Dec. 12, 2025
• Feb. 18, 2026Brilliance iCT… and 3 more productsClass IIAs part of the CT systems sub assembly, thirty-two (32) fasteners are used to attach the rotor to the bearing within the gantry. One or more of these… Recall began Jan. 7, 2026
• Feb. 11, 2026Willy Pete's Chocolates brand Almond Despair…Class IIIAlmonds are not declared in the ingredient statement. Almond is included in description of product on front label. Recall began Dec. 22, 2025
• Feb. 11, 2026Imu-Tek Immuno-5 Colostrum Powder 7 oz…Class IIUndeclared milk allergen Recall began Nov. 25, 2025
• Feb. 11, 2026Repackaged M&Ms Peanut candies… and 1 more productClass IIUndeclared allergens (milk, soy, and peanut)
• Feb. 11, 2026Product Name: Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio… and 6 more productsClass IICustomers may experience inaccurate test results by observing a higher frequency of classification in the indeterminate and positive zone and/or low… Recall began Dec. 11, 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, 2026Volk Single Use Vitrectomy Lenses 1… and 12 more productsClass IIThere may be voids located in the seal of Tyvek pouches associated with identified catalog numbers and lots. A compromised sterile barrier has… Recall began Dec. 16, 2025
• Feb. 11, 2026Focalyx FusionClass IISoftware device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not… Recall began Dec. 23, 2025
• Feb. 11, 2026MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G…Class IIA software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting… Recall began Nov. 2, 2025
• Feb. 11, 2026CellMek SPS Sample Preparation System…Class IISample preparation system designed to automate staining, lysing, cell washing has a software error that causes samples to be dispensed close to or… Recall began Dec. 23, 2025
• Feb. 11, 2026EMPOWR 3D Knee Tibial Insert 5R 14MM… and 1 more productClass II942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices… Recall began Jan. 5, 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, 2026Qunol…Class IIMold contamination detected for raw material lots that were produced in July and used in finished goods. Recall began Dec. 16, 2025
• Feb. 4, 2026BEAR Implant…Class IIIncorrect expiration date on label that extends beyond the product's documented/approved shelf life. With an incorrect expiration date, the UDI will… Recall began Dec. 31, 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
• Feb. 4, 2026Evolution Upgrade 1.5T… and 12 more productsClass IIThe potential for stiffness value errors when viewing exported MR Elastography (MRE) stiffness maps to viewer Picture Archiving and Communication… Recall began Dec. 3, 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, 2026Fran s PureBar Almondmilk Chocolate 46% Madagascar Plant-Based…Class Iundeclared hazelnut. Recall began Dec. 20, 2025
• Jan. 21, 2026Pulsator Arterial Blood Sampling Kit… and 1 more productClass IIAffected lots of syringes may have a crack on the syringe collar, which may lead to delayed or repeated blood draw/fluid delivery. This issue may… 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, 2026da Vinci SP…Class IIAccess Port System tray may develop cracks potentially resulting in a sterility breach. Recall began Dec. 15, 2025
• Jan. 21, 2026Asserachrom HPIA…Class IIPotential for defect for Asserachrom HPIA lot 271288, which can affect every well in the impacted strip and produce negative results. Recall began Dec. 15, 2025
• Jan. 21, 2026Boston Scientific Coyote OVER-THE-WIRE PTA Balloon Dilation Catheter…Class IIBoston Scientific is initiating the removal of certain batches of Coyote" Over-the-Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Balloon… Recall began Dec. 3, 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. 21, 2026FreeStyle Libre 3 Sensor REF 72081-01 UDI-DI code: 00357599818005 The… and 3 more productsClass IDue to a manufacturing process issue that may cause carbon build up in the sensor that may result in incorrect low glucose results Recall began Nov. 24, 2025
• Jan. 14, 2026Bengal King Jhal Chanachur food treats 12.34oz (350gm)Class IContains undeclared peanuts Recall began Dec. 12, 2025
• Jan. 14, 2026waterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON… and 1 more productClass IIShrimp may be contaminated with Cesium-137 (Cs-137).
• Jan. 14, 2026Locatelli Grated Pecorino Romano 4 oz and 8 oz plastic cup & lid… and 7 more productsClass IProduct tested positive for Listeria Monocytogenes. Recall began Nov. 21, 2025
• Jan. 14, 2026Snack Crackers 100to en boca (ciento en boca) Rovira… and 5 more productsClass IIUndeclared colors FD&C Yellow #6, and FD&C Red 40
• Jan. 14, 2026Town Food Service EQ CO Inc. brand Aluminum Sauce Pans in 1QT…Class IIProduct found to contain leachable lead levels. Recall began Oct. 17, 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. 14, 2026Philips Tempus Pro Patient Monitor…Class IIPatient monitor measures Intracranial Pressure (ICP) and Bladder Pressure (BDR) but ICP and BDR measurements have not been tested or validated for… Recall began Nov. 26, 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, 2025First & Last Tavern Traditional Pasta Sauce (meat flavored) 26 FL OZ… and 2 more productsClass IIMay be contaminated with Clostridium botulinum Recall began Oct. 31, 2025
• 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, 2025Zen Cleanse Blend herbal tea…Class IIPotential Salmonella contamination Recall began Nov. 24, 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, 2025Brand Name: Diasol Product Name: 100225-10-DEX100… and 5 more productsClass IISafety and efficacy of dialysis acid concentrate cannot be assured Recall began Nov. 5, 2025
• Dec. 31, 2025Brand Name: Affixus Antegrade Femoral Nailing System Product Name… and 16 more productsClass IIAffected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk…
• Dec. 31, 2025da Vinci 5…Class IISurgical system Error 23062 due to connector1) Partially damaged "Potential problem with ergonomics: Disable - Retry " or 2) Failed "Disable… Recall began Aug. 21, 2024
• 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, 2025Celebration Herbals Senna Leaf Herbal Tea 24 Teabags…Class IIpossible salmonella
• Dec. 24, 2025BaiLiFeng Dried Cinnamon Powder…Class IIcontains high levels of lead (10.7 mg/kg) Recall began Oct. 24, 2025
• Dec. 24, 2025Food to Live brand ORGANIC MORINGA LEAF POWDER… and 1 more productClass IContaminated with Salmonella Recall began Nov. 11, 2025
• Dec. 24, 2025Chef brand Milk Pan 24cmClass IIProducts found to contain leachable lead levels (3.00 mg/L) Recall began Nov. 19, 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, 2025InPen App…Class IIWhen app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't… Recall began Nov. 13, 2025
• Dec. 24, 2025Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a…Class IIDue to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval. Recall began Oct. 9, 2025
• Dec. 24, 2025Brand Name: Rocket Product Name: Rocket 12Fg Seldinger Catheter… and 5 more productsClass IIIFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during… Recall began Nov. 7, 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. 24, 2025Intelerad InteleShare software…Class IISoftware intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are… Recall began Nov. 18, 2025
• Dec. 24, 20255008X CAREsystem +CLiC +CDXClass IISeveral software anomalies with the potential to impact patient treatment, of which one includes the possibility to result in treatment stop if… Recall began Oct. 25, 2025
• Dec. 17, 2025UPC 8 10248 03165 6 YELLOW Peaches PRODUCE OF U.S.A. NET WT. 4 LBS.… and 10 more productsClass IPotential contamination with Listeria monocytogenes. Recall began Oct. 28, 2025
• Dec. 17, 2025Outer-packaging: gimme! brand Decaf de Agua coffee pods…Class IIUndeclared caffeine
• Dec. 17, 2025Stuffed Foods brand Cacio e Pepe Arancini…Class IUndeclared Soy Protein Concentrate Recall began Nov. 12, 2025
• Dec. 17, 2025Doughy brand Chocolate Chip Cookie Dough…Class IProduct may be contaminated with Salmonella
• Dec. 17, 2025Ganirelix Acetate Injection…Class IIFailed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. Recall began Nov. 13, 2025
• Dec. 17, 2025DEXLOCK Achilles Repair Implant Kits…Class IIThere have been multiple complaints of drill bit fusing to the bushing/sleeve within the drill guide during use. Retrieving a replacement drill bit… Recall began Nov. 11, 2025
• Dec. 17, 2025Bard InLay Optima Size: 6 Fr… and 3 more productsClass IILabeling discrepancy; Ureteral stent actual size may not match the actual product label. Recall began Nov. 6, 2025
• Dec. 17, 2025Brand Name: CONSTRUX" Mini PTC Spacer System Product Name: CONSTRUX"… and 5 more productsClass IIILabeling contains claims that are not consistently present. Recall began Nov. 3, 2025
• Dec. 10, 2025Genepro Whey 4th Generation Plasma Treated Protein…Class IProduct is mislabeled - the labeling contains incorrect ingredient information and fails to declare milk as an allergen
• Dec. 10, 2025Aojia Dried Red Bayberry…Class IIProduct contains undeclared sulfites (7.39mg/serving) and cyclamates Recall began Oct. 9, 2025
• Dec. 10, 2025Prenate Chewable A chewable Rx prenatal vitamin with a delicious chocolate flavor with Quatrefolic Dietary…Class IIIUndeclared Soy. The firm received positive test results for soy which is not listed on the label. The firm also noticed that the amount of boron in… Recall began Oct. 29, 2025
• Dec. 10, 2025Lava Bun with Green Tea Flavor bright lime green packaging (Frozen)… and 1 more productClass IIProducts do not declare milk in the Contains statement or the ingredient statement.
• Dec. 10, 2025Pacific Seafood Raw Blackened Shrimp Peeled & Deveined Tail-Off…Class IIIUndeclared Sulfite. Shrimp may contain 3.4mg Sulfur Dioxide per serving and label does not declare Sulfite. Recall began Nov. 8, 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, 2025Blonde Beard's Dojo Asian Wing Sauce…Class IIUndeclared Soy Recall began Oct. 31, 2025
• Dec. 10, 2025Haloperidol Lactate Injection…Class IILabeling: Not Elsewhere Classified:Incorrect RFID tag labels applied to product by repackaging firm. Recall began Oct. 10, 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. 10, 2025InSure ONE Fecal Immunochemical Test…Class IIInSure ONE failed sensitivity testing when used with Test Card Lot T241102, which may result in false negative results. Recall began Sept. 17, 2025
• Dec. 9, 2025Ghanaianway Restaurant and Grocery LLC Recalls Fresh Salted Lamb Products Produced Without Benefit of…Class IProduced Without Benefit of Inspection
• Dec. 3, 2025Cold Form Wrap: Back…Class IIThe IFU (Information for Use) on the wrap instructs the user to heat the hot and cold compression wrap in the microwave for 3 minutes, which may… Recall began Sept. 25, 2025
• Dec. 3, 2025Brand Name: Galaxy System Product Name: Galaxy System Model/Catalog Number: GAL-001 Product Description: The…Class IIDue to Users not having access to the Instructions for Use/User Manual due to it being password protected. Recall began Sept. 12, 2025
• Dec. 3, 2025CareLink Clinic…Class IISoftware error causing incorrect data to be displayed on the 24-hour Sensor Glucose Overview Graph, any potential therapy decisions were made based… Recall began Oct. 21, 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, 20251. CAMHB W/LHB…Class IIProducts may contain contamination, which may result in a darker or brown media color.
• Dec. 3, 2025CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K…Class IIXXX Recall began Sept. 15, 2025
• Nov. 26, 2025Rockport Lobser Bisque…Class IProducts contain undeclared shrimp (crustacean shellfish)
• Nov. 26, 2025Brand Name: ACUSON… and 1 more productClass IIAffected catheters were reprocessed beyond validated cycles. This may compromise device sterility or mechanical integrity of the device and can lead… Recall began Oct. 8, 2025
• Nov. 26, 2025Brand Name: Vacuette Product Name: 8 ml CAT Serum Separator Clot Activator Model/Catalog Number: 455071P…Class IISome of the Vacuette CAT Serum Separator Clot Activator tubes were manufactured without gel separator, which could yield erroneous assay results and… Recall began Aug. 19, 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. 26, 2025BD Luer Tip Caps…Class IIBD has confirmed through internal testing that certain device trays failed routine biocompatibility testing. Recall began Oct. 14, 2025
• Nov. 26, 2025TMJ Bilateral Implant REF: CHG020 Sterile EO…Class IPatient-fitted temporomandibular joint implant contained discrepancy in screw hole position. Recall began Oct. 13, 2025
• Nov. 19, 2025Product Name: Nutra Calm Package: 175cc HDPE Bottle… and 2 more productsClass IIProducts contains Magnesium Salicylate. Recall began June 18, 2025
• Nov. 19, 2025Ceiling Type X-Ray Tube Support Models CH-200 and CH-200M used with RADspeed…Class IIDue to an issue (potential breakage) with the shaft for the mounting of the X-ray tube assembly that could potentially result assembly coming off the… Recall began Oct. 16, 2025
• Nov. 19, 2025Applied Medical Technology… and 4 more productsClass IIThe nasal feeding tube may be occluded Recall began Oct. 6, 2025
• Nov. 19, 2025Anesthesia Circuit Kits and other various kits that contain… and 9 more productsClass IFirm received multiple complaints of anesthesia circuit leaks due to cracks in the 120" expandable tubing. Cracks and resulting leaks may lead to… Recall began Oct. 10, 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, 2025Frozen Crab Paste…Class IUndeclared allergen ingredients (fish, soy, and wheat) Recall began Oct. 3, 2025
• Nov. 12, 2025SYNCHRON Systems Direct LDL Cholesterol (LDLD) Reagent…Class IIBeckman Coulter has identified that there is an increased probability Synchron Systems Direct LDL Cholesterol (LDLD REF 969706) reagent lot M404166… Recall began Sept. 17, 2025
• Nov. 12, 2025Brand Name: Leksell Stereotactic System Product Name: Leksell Vantage Stereotactic System Software Version…Class IIDue to increased risk that paint flakes from the engravings may separate from the device and there is the possibility that the flake may… Recall began Sept. 30, 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. 12, 2025Brand Name: Inclusive Product Name: Inclusive Titanium Screw compatible with: Biomet 3i" Certain…Class IIIncorrect titanium screw, packaged with dental implant. Recall began Sept. 30, 2025
• Nov. 5, 2025MIXED NUTS Roasted & Salted… and 1 more productClass IIUndeclared Tree Nut. The firm discovered that Hazelnuts was not listed in the allergen statement Recall began Sept. 15, 2025
• Nov. 5, 2025Fusia Asian Inspirations brand Veggie Spring Rolls…Class IUndeclared shrimp
• Nov. 5, 2025Xpert SA Nasal Complete Catalog Number: GXSACOMP-10 UDI-DI code: 07332940000158 Xpert SA Nasal Complete kit…Class IIAs a result of Post-Market half-time stability testing, false negative test result was observed for a positive sample type. Recall began Aug. 6, 2025
• Nov. 5, 2025CellMek SPS Sample Preparation System…Class IIAutomated pipetting, diluting and specimen processing workstations for flow cytometric analysis device instructions for use list incorrect dead… Recall began Sept. 8, 2025
• Nov. 5, 2025SAFE-T-FILL Micro Capillary Blood Collection…Class IIAll RAM SAFE-T-FILL Micro Capillary Blood Collection tubes manufactured between July 31, 2023 to February 28, 2025 cause false positive results when… Recall began May 5, 2025
• Nov. 5, 2025ChemoLock Bag Spike… and 37 more productsClass IIPort weld of drug transfer device may separate or break during use and potentially result in a leak. Recall began Sept. 8, 2025
• Nov. 5, 2025Alcon PRECISION1 One-Day Contact Lenses…Class IIPotential for a weak seal in some units resulting in compromise in sterility. Recall began Sept. 30, 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
• Nov. 5, 2025Brand Name: MEGA Ballast Distal Access Platform Product Name: Mega Ballast Model/Catalog Number: MEGABT09180…Class IDue to an identified manufacturing defect involving coating material lifting within the catheter's distal inner diameter/lumen. Recall began Sept. 25, 2025
• Oct. 29, 2025Arctic Shores… and 4 more productsClass IIProduct manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137). This is an expansion to the original… Recall began Sept. 23, 2025
• Oct. 29, 2025Floria Dried Apricots…Class IProduct contains undeclared sulfites. Recall began April 29, 2025
• Oct. 29, 2025LOW PROF LCKNG SCREW… and 1 more productClass IIAlthough the etched length on the screw is correct, the length marked on the external packaging is incorrect. Specifically, 42mm screws were packaged… 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, 20256+ Months SPROUT ORGANICS Made With Organic Sweet Potato…Class IIPotential contamination with heavy metal (Lead). Recall began Sept. 16, 2025
• Oct. 22, 2025Gluten Free Bean & Rice Burrito…Class IIPotential contamination with foreign objects.
• Oct. 22, 2025CONTINU-FLO Solution Set… and 15 more productsClass IIIV sets may leak. Recall began Aug. 29, 2025
• Oct. 22, 2025Brand Name: Branding is not applied to this product… and 2 more productsClass IIDue to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose… Recall began Sept. 5, 2025
• Oct. 22, 2025DuoDERM" Extra Thin dressings are highly flexible…Class IIWound dressing may have foreign matter on the product. Recall began Aug. 29, 2025
• Oct. 22, 2025Airvo 2…Class IIWhen unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound… Recall began Sept. 18, 2025
• Oct. 22, 2025XERF EFFECTOR 60…Class IIManufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients. Recall began Sept. 4, 2025
• Oct. 22, 2025Neuroguard IEP 3 in 1 Carotid Stent and Post-Dilation Balloon System with Integrated Embolic Protection…Class IICarotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully… Recall began Sept. 4, 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, 2025Scott & Jon s Honey Sesame Salmon Rice BowlClass IIIcontains undeclared wheat
• Oct. 15, 2025Kirkland Signature brand Ahi Tuna Wasabi Poke…Class IListeria monocytogenes. Recall was initiated after being notified by green onion supplier of a Listeria monocytogenes positive test result in the…
• Oct. 15, 2025NutraGlide Nasal Feeding Tube with Stylet and ENFit… and 3 more productsClass IIThe nasal feeding tubes, NutraGlide, subject to this recall have distal tips that may detach at lower than expected forces. Recall began Aug. 12, 2025
• Oct. 15, 2025PERIFIX FX Continuous Epidural Anesthesia Tray with PERIFIX 17 Ga… and 12 more productsClass IIPotential for the lid of the catheter connector to be in the incorrect position.
• Oct. 15, 2025SYNCHRON Systems Phosphorus (PHOSm) Reagent REF: 467868 For In Vitro Diagnostic Use…Class IISpecific SYNCHRON Systems Modular Chemistry Phosphorus (PHOSm REF 467868) reagent lots may fail calibration before the lot expiration date which… Recall began Sept. 3, 2025
• Oct. 15, 2025FDR Visionary Suite…Class IIIt was found that the shaft for mounting the X-ray tube unit on the support may break. In addition, it was found that the protective parts might not… Recall began Sept. 15, 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, 2025Orwashers brand Soho Sourdough XL Batard…Class IIMislabeled: Product may contain undeclared sesame seeds
• Oct. 8, 2025Venclose digiRF Generators…Class IISoftware version 3.35 of the Venclose digiRF Generator incorporates a catheter verification feature specifically designed to detect internal wiring… Recall began Aug. 21, 2025
• Oct. 8, 2025JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT)…Class IIDevice used for unilateral or bilateral occlusion of blood flow to the lower limbs has a potential manufacturing defect that may compromise the… Recall began July 1, 2025
• Oct. 8, 2025Brand Name: Atlan Product Name: Atlan A350 Model/Catalog Number… and 1 more productClass IThe device either indicated a failure of the piston ventilator before use or suffered a failure of the mechanical ventilation during use.
• 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. 8, 2025Artegraft Collagen Vascular Grafts Model Numbers: (1) AG 616…Class IIThe bovine carotid arteries used to produce the impacted grafts from affected lots were sourced using raw material from a supplier that had not been… Recall began Sept. 2, 2025
• Oct. 8, 2025Change Healthcare Radiology Solutions software version 14.2.2Class IIDue to software issue, radiology reports may not be fully displayed when viewing. Recall began Aug. 13, 2025
• Oct. 8, 2025IMPLANT EPIKUT PLUS MT16 3,5X10,0MM…Class IIDental implants were imported under temperature and storage conditions that do not comply with the instructions for use and product labeling so there… Recall began July 30, 2025
• Oct. 8, 2025Getinge 88-Series Washer- Disinfector…Class IIPotential for device to overheat during operation if the circulation pressure calibration was not performed or had been performed incorrectly, and… Recall began Aug. 29, 2025
• Oct. 1, 2025GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS… and 1 more productClass IUndeclared allergens (milk).
• Oct. 1, 2025Extractor Pro RX Retrieval Balloon Catheter…Class IIThe product in incorrectly labeled. The label indicates that the skive hole should be above the balloon, while it is actually positioned below, and… Recall began Aug. 28, 2025
• 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
• Oct. 1, 2025STRATAFIX Spiral PDS Plus Bidirectional Knotless Tissue Control Device…Class IIPotential for barb non-engagement. Recall began Aug. 15, 2025
• Oct. 1, 2025Automated Impella Controller (AIC) with the below brands and product codes…Class ISpecific Automated Impella Controllers (AICs) that have a Pump Driver Circuit Assembly do not meet current specifications. This may lead to decreased… Recall began Aug. 20, 2025
• Sept. 24, 2025CHARGE-UP CHILAQUILES Traditional Mexican breakfast consisting of… and 1 more productClass IIUndeclared Yellow #5 and Yellow #6. Recall began Aug. 20, 2025
• Sept. 24, 2025(Bulk) Oyster…Class IIOyster product potentially contaminated with Norovirus Recall began Aug. 7, 2025
• Sept. 24, 2025Sand Bar… and 1 more productClass IIProduct manufactured under insanitary conditions whereby it may have been contaminated with Cesium-137 (Cs-137) Recall began Aug. 19, 2025
• Sept. 24, 2025FORMUTECH NUTRITION FLEXIBLE JOINT FORMULA WITH CISSUS QUADRANGULARIS… and 15 more productsClass IIIUnapproved Drug Claims. Recall began Aug. 6, 2025
• Sept. 24, 2025SureStep Foley Tray System Bardex I.C… and 2 more productsClass IIFoley catheter trays have incorrect inserts, user may think:1)Silicone, when it's natural rubber latex, or 2)Natural rubber latex with infection… Recall began July 17, 2025
• Sept. 24, 2025UniCel DxH 900 COULTER Cellular Analysis System… and 3 more productsClass IIHematology analyzers configured with HGB photometers may result in erroneously high hemoglobin (HGB) results on samples with elevated white blood… Recall began Aug. 13, 2025
• Sept. 24, 2025Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code…Class IIDue to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet… Recall began Aug. 5, 2025
• Sept. 24, 2025Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy… and 2 more productsClass IITheir is the potential for weak staining which may result in false negative CD20 identification. Recall began Aug. 11, 2025
• Sept. 24, 2025Exactech Equinoxe… and 1 more productClass IIReverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling. Recall began Aug. 15, 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. 17, 2025QuickVue: Dipstick Strep A Test: 50T…Class IIDipstick strep A test has potential for false positive results. Recall began June 17, 2025
• Sept. 17, 2025CorNeat EverPatch…Class IIRetroactive; Due to complaints, labeling correction for permanent tissue-integrating surgical matrices to include prevention and management of would… Recall began Oct. 16, 2024
• Sept. 17, 2025Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog…Class IIUnits may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the… Recall began July 30, 2025
• Sept. 17, 2025Artis Pheno…Class IILimited system movements after startup . Recall began Aug. 12, 2025
• Sept. 10, 2025FSIS Issues Public Health Alert for Raw Sirloin Beef Tip Product Due to Misbranding and Undeclared AllergensMisbranding; Unreported Allergens
• Sept. 10, 2025Hans Kissle Red Bliss Potato SaladClass IIContains undeclared wheat. The top label identifies the product as potato salad, but the unit contains pasta salad. Recall began Aug. 4, 2025
• Sept. 10, 2025Brand Name: 900-00218 Sterile Cover 10-Pack Shipper Box Assembly Product Name: 900-00218 Sterile Cover…Class IIThe potential of the elastic bands included in the kit detaching or fracturing during surgical procedures. As a result, these failures may pose a… Recall began July 31, 2025
• Sept. 10, 2025Medshape Universal Joints…Class IIBone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in… Recall began June 2, 2025
• Sept. 10, 2025Brand Name: MediHoney Product Name: MediHoney Paste Model/Catalog… and 7 more productsClass IIPackaging failures were identified which could lead to a breach in the sterile barrier. Recall began Aug. 5, 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, 2025Hostess Ding Dongs CHOCOLATE CAKE WITH CREAMY FILLING 2.55 oz twin pack…Class IIMold. The firm noticed an increase in customer complaints. They conducted a root cause investigation and discovered that one of their coolers had…
• 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, 2025Bardex Lubri-Sil I.C…Class IIFoley catheter may have an obstructed lumen, which may result in an inability to drain the bladder, of urine and may include pelvic or abdominal… Recall began June 18, 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
• Sept. 3, 2025ELEOS SEGMENTAL LIMB SALVAGE SYSTEM… and 2 more productsClass IIUnidentified substance of unknown impact was identified on devices during a retrospective evaluation. Recall began July 11, 2025
• Sept. 3, 2025Brand Name: Atlantis IO FLO-S Product Name: Atlantis IO FLO-S Kit… and 1 more productClass IIThe defect in the thread area will not allow the device to fully engage with an implant or analog (implant replica used for prosthetic modeling). The… Recall began July 24, 2025
• Sept. 3, 2025Brand Name: THOR Product Name: NovoTHOR Model/Catalog Number: S2188… and 3 more productsClass IIThe potential for a failed welded nut to shear off. When this occurs, the gas strut on one side of the device becomes detached from the canopy… Recall began July 24, 2025
• Aug. 27, 2025Sri Sri Tattva…Class IIProduct contains undeclared soy lecithin.
• 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, 2025Signature Cafe Premium Tuna Salad… and 6 more productsClass ITuna Salad products are recalled due to potential contamination with Listeria monocytogenes because products containing Newly Weds Foods recalled… Recall began July 16, 2025
• Aug. 20, 2025Quesito El Establo brand Spanish Cheese QUESITO COLOMBIANO…Class IProduct was manufactured and held under insanitary conditions. Product may be contaminated with Listeria monocytogenes.
• Aug. 20, 2025Clover Valley Instant Coffee…Class IIPotential presence of glass pieces
• Aug. 20, 2025Sukhi's CLASSIC CURRY PASTE… and 3 more productsClass IIPotential contamination with foreign objects (metal pieces).
• Aug. 20, 2025Zvu Anorectal Manometry Procedure Kit…Class IIIAnorectal manometry procedure kit outer kit label is mislabeled with an incorrect expiration date; the manufacturing date was used in place of the… Recall began June 4, 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, 20253mensio Workstation (Vascular Fenestrated) softwareClass IIWhen fenestrated analysis with clock measurements is started in diagnostic bioimaging software (intended to measure/visualize cardiovascular… Recall began July 14, 2025
• Aug. 20, 2025High Pressure Tubing: REF: 502211002… and 3 more productsClass IIHigh pressure tubing may relax over time causing it to partially separate from the connector resulting in a void that can trap air in the line. Use… Recall began June 5, 2025
• Aug. 20, 2025Brand Name: HeartMate Product Name: Mobile Power Unit… and 1 more productClass IDue to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile… Recall began June 23, 2025
• Aug. 20, 2025Brand Name: Carefree Surgical Specialties Product Name… and 3 more productsClass IIDue to two issues: 1. Product contamination (biological foreign matter) that could compromise sterility. 2. Incorrect quantity of gauze in sterile… Recall began July 1, 2025
• Aug. 13, 2025ARAL FISH…Class IClostridium botulinum (uneviscerated fish) Recall began June 18, 2025
• Aug. 13, 2025Favorite Day Bakery Frosted Sugar Cookies…Class IIForeign Material (wood)
• Aug. 13, 2025Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol… and 12 more productsClass IILack of Processing Controls.
• Aug. 13, 2025One-piece Guedel airway… and 1 more productClass IIPotential contamination with small burrs, which if detach could be inhaled and result in potential complications such as airway obstruction, tissue… Recall began June 20, 2025
• Aug. 13, 2025Brand Name: T4 Total ELISA Product Name: T4 Total ELISA Model/Catalog Number: EIA-4568 Product Description…Class IIIAn incoming complaint reported that the expiration date on the kit box label and Certificate of Analysis (CoA) exceeded the shelf life of the… Recall began June 4, 2025
• Aug. 13, 2025BD Trucount Controls… and 1 more productClass IIControl kits contain incorrect standard deviation (SD) values for the low and high control beads which compromises the accurate calculation of bead… Recall began July 8, 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. 13, 2025Microbore Extension Set with 0.2 Micron Filter…Class ILabel is incorrect. The product label indicates that the device contains an air eliminating filter. However, the filter utilized on this extension… Recall began July 9, 2025
• Aug. 6, 2025Reisman's Jumbo Colored Sprinkles Cookies 3 oz and 23 more productsClass IIUndeclared wheat and soy Recall began June 17, 2025
• Aug. 6, 2025LVP Primary Administration Set… and 3 more productsClass IIPotential for external cassette leaks Recall began June 24, 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, 2025Precision Sampling Set…Class IISampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds… Recall began April 21, 2025
• Aug. 6, 2025Phasor Drill…Class IIDrill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time. Recall began March 21, 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
• Aug. 6, 2025Breathing circuit set…Class IVentilator coaxial breathing circuit may have a crack in blue tubing, which is used to deliver fresh gas to the patient. The crack will compromise… Recall began June 26, 2025
• Aug. 6, 2025SafeStar 90 Plus Filter… and 3 more productsClass IReports of slow increase of CO2-curve when gas sample is taken from the gas sampling port of filters. Recall began June 16, 2025
• July 30, 2025Ritz Peanut Butter Cracker Sandwiches… and 3 more productsClass IIUndeclared allergens (Peanut) due to mispackaging
• July 30, 2025Middle East Coast brand Tahini Dip…Class IIProduct may be contaminated with spoilage organisms. Recall began June 20, 2025
• 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, 2025ACUVUE OASYS MAX 1-Day MULTIFOCALClass IIDue to defects (bubbles/voids) identified during standard finished goods testing Recall began June 12, 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, 2025Dubai emek SPREAD PISTACHIO CACAO CREAM WITH KADAYIF…Class ISalmonella. The firm was notified by the FDA that the product may be contaminated with Salmonella.
• July 23, 2025Chocolate Crunch Cake Bar (85000)… and 9 more productsClass IIPotential Listeria Monocytogenes Contamination
• July 23, 2025SwabCap Disinfecting Cap for Needlefree Connectors: SwabSleeve…Class IIDue to a manufacturing issue, disinfecting cap for needle-free connectors may have an incomplete seal between the foil lid and plastic container… Recall began June 3, 2025
• July 16, 2025Wegmans Semi-Sweet Chocolate Nonpareils…Class IIUndeclared milk Recall began June 16, 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, 2025TrueDent Clear… and 4 more productsClass IIICustomers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will… Recall began Jan. 19, 2024
• 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, 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 9, 2025BD Heyman Follower Straight Tip for following sizes: 10Fr… and 2 more productsClass IICather packaging may contain the incorrect French size. Recall began June 3, 2025
• July 2, 2025FIREHOOK ARTISAN BAKED CRACKERS CLASSIC SEA SALT…Class IIUndeclared Sesame. The firm was notified by a retailer that product labeled as Sea Salt Bagel Crackers contained Everything Bagel Crackers. The… Recall began May 30, 2025
• July 2, 2025Spectral CT…Class IIDevices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or… Recall began May 29, 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, 2025Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX… and 3 more productsClass IIPackage labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product. Recall began May 28, 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, 2025Lancaster LF Authentic Greek Salad Kit…Class ISalmonella. Greek Salad Kit made with recalled cucumbers sourced from Bedner Grower's Company which may be contaminated with Salmonella and… Recall began May 21, 2025
• June 25, 2025Big Y various sandwiches made to order at deli counter (Subs (small…Class IContains cucumber contaminated with Salmonella recalled by Bedner Growers Inc. Recall began May 21, 2025
• June 25, 20255008X HDF Hemodialysis Blood Tubing Set…Class IIPotential of blood leak occurring between the lower port of the venous chamber and the tubing include: hemodiafiltration (HDF), hemodialysis (HD)… Recall began April 29, 2025
• June 25, 2025ICU Medical Plum Duo… and 1 more productClass IIInternal testing found that Plum Duo pumps with software version 1.1.1 have a workflow that may result in bypassing the Maximum Dose Limit alert. The… Recall began April 22, 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, 2025Smartcuts Cucumber Sliced Trays 2/2lbClass IContaminated with Salmonella
• June 18, 2025Cucumber 24 Ct Repacked by Lipman Produce Hendersonville… and 4 more productsClass IPotential Salmonella Contamination
• 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, 2025Alaris Pump Infusion Set: SmartSite Bag Access Non-Vented Bonded… and 4 more productsClass IISterile, single use closed system drug transfer devices, standalone or on infusion sets or bonded syringes, may leak at the interface between the… Recall began May 12, 2025
• 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 18, 2025Microtek Patient Drape ECOLAB AP6MMN Patient Drape…Class IIDue to non-sterile products being labeled as sterile Recall began April 13, 2025
• June 18, 2025Achieva XR Product Numbers: (1) 781153… and 8 more productsClass IIidentified an issue where a component failure in the specific Gradient Coil type of affected systems can potentially act as a heat source, with a…
• June 18, 2025SCD Comfort Knee Length Small… and 2 more productsClass IIIncorrect software logic may cause frequent E1 errors (system high pressure). Issue may cause delay in treatment or therapy. Recall began May 13, 2025
• June 18, 2025Newport HT70 Ventilator…Class IVentilator Printed Circuit Board Assembly may have two separate capacitors that may fail, which may result in the ventilator either shutting down…
• 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, 2025Best Taste Brand Salted Shrimp Paste Sauce…Class IIIProduct contains undeclared FD&C Red #3
• June 11, 2025Bengal King Family Pack Vegetable SingaraClass IContains undeclared peanut
• June 11, 2025GNC Women's 30+ Vitapak…Class IIIUndeclared Fish allergen (parvalbumin). Recall began April 25, 2025
• June 11, 2025Nordic Naturals Zero Sugar Kids Multivitamin Supplement…Class IIIProduct is mislabeled. Recall began May 2, 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 11, 2025Medline Kits containing Codman Disposable Perforator 14 mm: 1… and 2 more productsClass IAffected kits contain recalled Integra Lifesciences Codman Disposable Perforators due to inadequate welds on specific lots. Perforators with… Recall began April 22, 2025
• June 4, 2025Catalog No… and 5 more productsClass IIPackaging defect may compromise sterility of the product. Use of a non-sterile product on the patient could lead to infection in neonates. Recall began May 2, 2025
• June 4, 2025GM Helix Acqua Implant… and 1 more productClass IIIt is possible that a package labelled as an 11.5 mm implant may contain a 13 mm implant instead. Recall began May 1, 2025
• June 4, 2025DORO Easy-Connect Navigation Adaptor…Class IIPotential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the… Recall began March 14, 2025
• June 4, 2025Ultrasonic Cleaning Systems Triton 36 Model Number 6003000804 Triton 72 Model Number 6003000805 Ultrasonic…Class IIDuring routine preventative maintenance checks, it was revealed that carbon filter sensors were breaking down due to electrochemical degradation. Recall began March 31, 2025
• June 4, 2025Glidewell HT Implant Twist Drill 1.5 x 8 mm " SKU # 70-1071-SRG0266 UDI code…Class IIDue to packaging mix up. Package of finished devices were reported to have an incorrect finished device package inside. Recall began April 14, 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, 2025PhenoMATRIXClass IIAI-powered bacterial culture plate interpretation and workup software does not have Premarket Approval or pre-market notification (510(k)/de novo)…
• May 28, 2025BD Cathena Safety IV Catheter BD Multiguard Technology 18 GA x 1.25 IN…Class IIDue to a manufacturing defect IV catheter may have a hole in the septum, which may result in blood leakage from the septum during insertion, which… Recall began April 21, 2025
• May 28, 2025TRUE 3D VIEWER SYSTEM Model Number EP-00001-XX Software versions 1.0…Class IIImaging system data may be displayed with an incorrect orientation (sidedness) where the patient side is not correct (left, right, superior… Recall began April 11, 2016
• May 28, 2025META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM…Class IIIntegrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional… Recall began March 18, 2025
• May 28, 2025True 3D Viewer…Class IIWith certain software versions, import of enhanced ultrasound formatted data/ultrasound images into 3D viewer, (for digital image… Recall began Feb. 21, 2018
• 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 21, 2025National brand Kasundi PEELED MANGO PICKLE IN OIL…Class IIProduct contains elevated levels of lead (0.0649 mg/kg) Recall began April 16, 2025
• May 21, 2025Tomatoes…Class IPotential Contamination of Salmonella.
• May 21, 2025H&C Farms Raw Premium Tomatoes…Class IPotential Salmonella Contamination
• May 21, 2025Bonya Strawberry Yogurt Parfait… and 11 more productsClass IUndeclared Almonds Recall began March 29, 2025
• May 21, 2025DxC 500 AU Clinical Chemistry Analyzer…Class IIBeckman Coulter is recalling their DxC 500 AU Clinical Chemistry Analyzer because a software error causes the analyzer to not run a requested… Recall began March 20, 2025
• May 21, 2025KliniTray… and 1 more productClass IIPotential for microbial contamination. Recall began April 4, 2025
• May 21, 2025LifeShield Drug Library Management (DLM)…Class IIFirm has identified Drug Library Management defects in the software: 1) DLM software does not allow user to create percentage dose rate or rate…
• May 21, 2025Brand Name: Contour Product Name: Contour Gold Eyelid Weight… and 1 more productClass IIDue to mislabeling of products Recall began July 12, 2024
• May 21, 2025MedicaLyte Liquid Bicarbonate Concentrate…Class IPotential for the presence of visible foreign matter. Recall began April 11, 2025
• May 14, 2025GALT Centeze Catheter REF: DRC-002-05 DRC-002-06 The Centeze is… and 6 more productsClass IIDue to a potential open seal in the sterile barrier packaging . Recall began March 27, 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 13, 2025FSIS Issues Public Health Alert for Ready-To-Eat Chicken and Bacon Wrap Products Due to Possible Listeria…Product Contamination
• May 7, 2025Enhanced Verify Evaluation Handset (CFN HH90130FA)Class IIEvaluation handsets may not be able to communicate with the neurostimulator due to handsets having a faster processing speed than prior handsets. An… Recall began April 3, 2025
• 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
• May 7, 2025DxC 500 AU Clinical Chemistry Analyzer…Class IIThe reason for the recall is incorrect sample barcode identification and processing errors that result in the reporting of erroneous and delayed… Recall began March 17, 2025
• April 30, 2025Blue Ridge Beef Kitten Mix For Cats… and 1 more productClass IPossible contamination with Salmonella and Listeria monocytogenes
• April 30, 2025Label: IQF CILANTRO LARGE… and 1 more productClass IIPotential contamination with foreign objects.
• April 30, 2025Tempus Pro Patient Monitor…Class IIsoftware issue that causes an error screen on a portable vital signs monitor when attaching video Laryngoscope.
• April 30, 2025Skytron Freedom 4FXS-60 Heavy Duty Monitor MountClass IIThe mounting hardware that is supplied with the 4FXS-60 monitor bracket does not provide adequate thread engagement to support the weight of the… Recall began March 27, 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, 2025Brand Name: CELL-DYN Ruby Product Name: CELL-DYN Ruby Model/Catalog… and 4 more productsClass IIWhen expired reagents are scanned or manually entered, the system will change the expiration date to current or future date without notifying user… Recall began March 18, 2025
• April 30, 2025InPen smart insulin pen…Class IIInsulin pens may have been incorrectly assembled therefore users could experience the following: either the insulin cartridge will not fit into the… Recall began March 4, 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, 2025Golden Crop Candy (10 oz… and 1 more productClass IIContains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18) Recall began March 5, 2025
• April 23, 2025LEMON PLUM…Class IIIProduct contains cyclamates. Recall began Feb. 7, 2025
• April 23, 2025PANADERIA/BAKERY Salvadorena…Class IIProduct contains undeclared milk.
• April 23, 2025BaiWei ShanZhuang…Class IIIProduct contains cyclamates Recall began March 4, 2025
• April 23, 2025Trader Joe's Hot Honey Mustard Dressing (SKU #80152)…Class IUndeclared peanuts, soy, sesame, and wheat.
• April 23, 2025Farmer House Preserve Olive StripsClass IIIContains Cyclamates Recall began March 11, 2025
• April 23, 2025Guide Wire with Ruler Tube 3x800 mm DIA… and 1 more productClass IIThe metal ring at the end of the Guide Wire with Ruler Tube may detach from the main body of the instrument during use in surgery.
• 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, 2025MEDFLEX…Class IIIf "Clear All" selected medications is selected on patient profile, the automated dispensing cabinet may allow dispensing of medication without first… Recall began Oct. 5, 2023
• April 23, 2025Brand Name: Ballard Product Name: Closed Suction Catheters… and 7 more productsClass ILack of sterility assurance for closed suction catheter systems Recall began March 19, 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, 2025Dried Cranberries (21.75 lb/case…Class IIMisbranded - label states 2g total carbohydrates instead of 27g Recall began March 17, 2025
• April 16, 2025Dr. Praeger s California Veggie Fries 8ozClass IIUndeclared Allergen (Soy)
• April 16, 2025BD Pyxis MedBank CUBIE Replenishment Station Product / Material ID BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P /…Class IIDue to a software issue, when attempting to restock the automated dispensing cabinet, user have received the banner message "Stocking window has… 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 16, 2025GenetiSure Dx Labeling Kit…Class IIDNA Labeling Kit for use in sample labeling to be hybridized to oligonucleotide microarrays has a component, Human Reference DNA Female aliquot…
• April 16, 2025stryker Blueprint Mixed Reality BP MxR Glenoid Pin Guide PPSU +… and 8 more productsClass IIStryker identified an elevated complaint rate related to difficulties using the Blueprint Mixed Reality Guidance Instrumentation system is… Recall began March 5, 2025
• April 16, 2025Hippo 072 Aspiration System including Cheetah Delivery Tool and Aspiration Tubing…Class IAspiration catheter distal tip features and characteristics may not be in the scope of FDA clearance; tip detachment, vessel rupture, and vasospasm… Recall began Feb. 26, 2025
• April 9, 2025Lean Cuisine Lemon Garlic Shrimp Stir Fry… and 2 more productsClass IIPotential foreign material (wood-like material)
• April 9, 2025DxC 500 AU Clinical Chemistry Analyzer…Class IIBeckman Coulter has determined that device software versions V1.3, V1.4, V1.4.1, V1.4.2, V1.4.3. have a defect due of which, when all constituent… Recall began Feb. 26, 2025
• April 9, 2025BD Connecta BD Luer-Lok 360…Class IIDue to specific lots of luer-lok devices were shipped to the U.S. market with an Outside US Instruction for Use (IFU) Recall began Feb. 20, 2025
• April 9, 2025Boppli: Bedside Device Kit…Class IISingle-use battery-powered blood pressure monitor, for use on neonates and infants, due to vibratory noise, may not adequately detect changes in… Recall began Feb. 24, 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.
• April 9, 2025Monterey AL Implant Inserter… and 3 more productsClass IIPotential for the gold unlock button to separate from the inserter. Recall began Feb. 28, 2025
• April 2, 2025Jinga Glass Noodles with vegetables 8 oz…Class IContains undeclared egg
• April 2, 2025NexGen LPS Flex…Class IIThe "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6"… Recall began Feb. 27, 2025
• April 2, 2025CardioMEMS Heart Failure (HF) System that consist of: -CardioMEMS Hospital System Model CM3100 -CardioMEMS…Class IIDue to issues associated with data migration of patient information and results to a Cloud service, the firm has received complaint associated with… Recall began Feb. 3, 2025
• April 2, 2025CVAC Aspiration System…Class IAspiration system, for endoscopic examination/treatment of urinary tract and kidney interior, to have labeling update adding additional instructions… Recall began Feb. 19, 2025
• March 26, 2025Synapse PACS Software Version 7.4.x…Class IIThe incorrect computed patient age is showing in VX for patients less than 3 months old. Recall began Feb. 11, 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, 2025Little Leaf Farms brand Southwest Salad Kit…Class IProduct may contain incorrect salad dressing, resulting in fish and wheat being undeclared.
• 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, 2025Aleppo Tahini Sesame Paste…Class IProduct tested positive for Salmonella Recall began Jan. 31, 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 12, 2025BD BBL TB Stain Kit K…Class IIOne component of the kit was shipped with an expiration date of 30Sep2024 while the Certificate of Analysis (COA) indicated an expiration date of…
• 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, 2025Philips IntelliSpace Cardiovascular software…Class IIStudy data is not able to be archived, copied, or exported with the cardiovascular software version. Recall began April 4, 2024
• March 12, 2025Brand Name: TBS Osteo Product Name: TBS iNsight Model/Catalog Number: TBS iNsight v3.x / pn: OS-TBSi Software…Class IIPotential variability in calculations from fast array scans compared to array scans when operating on Hologic Horizon machines. Recall began Feb. 3, 2025
• March 12, 2025Access Erythropoietin (EPO)…Class IIAffected lot (439363) exhibited a negative dose drop of -22% with native patient samples compared to alternate reagent lots. Patient samples tested… Recall began Feb. 3, 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 12, 2025Rotarex Atherectomy System and Instructions for Use…Class IAtherectomy Catheter eIFU updated to clarify and emphasize procedural steps intended to reduce the likelihood of catheter breakage events. Catheter… Recall began Feb. 5, 2025
• March 12, 2025VARIPULSE Bi-Directional Ablation Catheter REF D141201…Class IDue to an observed trend of neurovascular events Recall began Jan. 5, 2025
• March 5, 2025Gerber Snacks for Baby Soothe 'n' Chew TEETHING STICKS Strawberry… and 1 more productClass IFirm received complaints of infant choking. Recall began Jan. 31, 2025
• March 5, 2025DxC 500 AU Clinical Chemistry Analyzer…Class IIBeckman Coulter has identified an issue which prevents the DxC 500 AU instrument from providing the correct onboard stability (Open Expiration) dates… Recall began Jan. 10, 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, 2025AAHU BARAH brand SOFT PLUM…Class IIProduct contains undeclared sulfites (4.66 mg/serving). Recall began Jan. 9, 2025
• Feb. 26, 2025THREE RIVERS brand TUTTI-FRUTTI…Class IIProduct contains undeclared FD&C Yellow 5 and FD&C Yellow 6. Recall began Dec. 12, 2024
• Feb. 26, 2025Paras Premium Golden Raisins…Class IProduct contains undeclared sulfites (56.8mg/serving) Recall began Jan. 7, 2025
• Feb. 26, 2025LIFEPAK 15 V4/Masimo Rainbow Sensors: Masimo RD rainbow Adt 8 SpCO…Class IIDue to an error message that prevents users from utilizing carboxyhemoglobin saturation and methemoglobin saturation sensors on their… Recall began Jan. 21, 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. 26, 2025DeRoyal AMG Suction Connector Tubing REF: 71-2083…Class IIThe tubing may not ensure that the yankauer stays intact, and secure to the tubing / yankauer connection for a tight seal. This could result in… Recall began Jan. 15, 2025
• Feb. 19, 2025Brand Name: MediHoney Gel Product Name: MediHoney Wound & Burn Dressing Gel Model/Catalog Number: 31815…Class IIPotential that the induction seal is not completely sealed to the device tube packaging. Recall began Jan. 10, 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, 2025Product is individually packaged in opaque airtight plastic packaging with Chinese lettering on one side…Class IImported Monkfish Liver undeclared allergen (Milk)
• Feb. 12, 2025COLUSSI CANTUCCINI CHOCOLATE DROPS COOKIESClass IIContains undeclared visible almonds
• Feb. 12, 2025NuGo Dark Chocolate Pretzel with Sea Salt… and 2 more productsClass IThe product is being recalled because of undeclared milk . Recall began Nov. 27, 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. 12, 2025NeiMed NasoGel for DRY NOSES UDI-DI/…Class IIDue to nasal spray stability failure for bioburden. Recall began Dec. 28, 2024
• Feb. 12, 2025Integra Miltex CryoSolutions Cartridges 10 Pack (23.5g N2O each)… and 1 more productClass IIDuring the assembly of the cartridge to its connecting body part, the valve may open prematurely resulting in partial or complete emptying of the… Recall began Dec. 19, 2024
• Feb. 12, 2025Nobel Biocare N1 TiUltra TCC RP 4.0x9mm…Class IIDue to manufacturing issue (unintended by-product of the injection molding process) a sharp pin that may puncture the blister packaging and breaching… Recall began Jan. 10, 2025
• Feb. 12, 2025PROLENE Polypropylene Suture… and 2 more productsClass IISutures may have an open seal on the primary packaging, due to a manufacturing issue on a specific machine, and if issue is undetected could lead to… Recall began Dec. 20, 2024
• Feb. 12, 2025The Rapid fFN Specimen Collection Tube (PN: 71550-001) is a component of the Rapid fFN Specimen Collection…Class IIThree lots of Rapid fFN Specimen Collection kit (901164, 901165, and 904850) contain Rapid fFN Specimen Collection Tubes which may be empty… Recall began Jan. 8, 2025
• Feb. 12, 2025Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797Class IIMislabeling; Levofloxacin Antimicrobial susceptibility disc packaging may contain Norfloxacin Antimicrobial Susceptibility discs. Recall began Dec. 23, 2024
• Feb. 12, 2025SenTiva… and 1 more productClass IIVagus nerve stimulator generators may stop delivering stimulation due to an internal, mechanically activated component that may become stuck in a… Recall began Dec. 12, 2024
• Feb. 5, 2025Brand Name: SenTiva" Product Name: VNS Therapy" SenTiva"… and 1 more productClass IITheir is a potential that implanted pulse generators may stop delivering therapy due to an internal component issue. Recall began Jan. 3, 2025
• Feb. 5, 2025Infinity Central Station…Class IIEdifier speakers (shipped in or after April 2023) may not annunciate when configured in analog mode which can lead to delayed treatment to the…
• Feb. 5, 2025Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O…Class IIComplaints have been received regarding post-operative implant collapse. Recall began Dec. 15, 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, 2025Baxter Solution Set with Duo-Vent Spike… and 2 more productsClass IISpecific lots of Solution Sets with Duo-Vent Spike have the potential for inverted side clamps causing the tubing to be unusable. Recall began Dec. 20, 2024
• Jan. 29, 2025Brand Name: N/A Product Name: Repeater Bone Tamp Model/Catalog Number: ASY-00132 Software Version: N/A…Class IIDue to incompatibility of bone tamp (Rev A) and bone funnels (Rev C). 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

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