Recalls distributed in New Jersey

• 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, 2026Sempio Yellow Peach…Class IIelevated level of lead in canned peaches Recall began Sept. 24, 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, 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
• Oct. 28, 2026B Braun SAFSITE Injection Site…Class IIPotential for leakage and backflow at the Safsite valve. Recall began Sept. 14, 2026
• Oct. 28, 2026Philips Lumify Diagnostic Ultrasound SystemClass IUltrasound system may: 1) Not recognize previous transducer registration, prevent scanning, require re-registration with Wi-Fi/cellular access, which… Recall began Sept. 24, 2026
• Oct. 21, 2026The ABL90 FLEX and ABL90 FLEX PLUS analyzers are intended for use by trained technologists…Class IIIn vitro diagnostic analyzer had a risk of potentially inaccurate results requiring changes to instructions for use and: 1) Sample types, including… Recall began Aug. 18, 2026
• Oct. 21, 2026Convenience Kits containing CONMED AirSeal Access Ports ADVANCE… and 5 more productsClass IIKits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system… Recall began Aug. 31, 2026
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• 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, 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, 2026Power F2 Powered Fastening System…Class IIFirmware issue may result in intermittent loss or degradation of powered functionality when paired with compatible stretcher. The issue may lead to… Recall began April 28, 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, 2026SIERRA NEVADA CHEESE GRAZIERS RAW MILK SHARP CHEDDAR…Not Yet ClassifiedPotential contamination due to E. coli O26:H11.
• Oct. 14, 2026Lemon Blueberry Loaf packaged in a cardboard box… and 2 more productsClass IIProduct contains undeclared soybean oil and soy lecithin in the Ingredient Statement. Soy was not declared in the Contains statement. Recall began Sept. 4, 2026
• Oct. 14, 202628 oz. Gatorade Lemon Lime, Gatorade Lemon Lime Zero, Gatorade Orange, and Gatorade Orange ZeroClass IIUndeclared Yellow No. 6 and/or Yellow No. 5
• Oct. 14, 2026Intellijoint Navigation System: Workstation G2 Configured…Class IIA navigation system used to aid in selection and positioning of orthopedic implant system components has a workstation that may contain a 15-inch… Recall began Aug. 28, 2026
• Oct. 14, 2026TufTex Over-the-Wire Embolectomy Catheter…Class IIDevices failed in process testing related to the amount of pull force it can sustain prior to the balloon components failing. Recall began Aug. 28, 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, 2026Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062…Class IISome MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed… Recall began Aug. 20, 2026
• Oct. 14, 2026BARD EP XT DECAPOLAR STEERABLE…Class IIDiagnostic electrophysiology (EP) catheter may have a breached sterile barrier on the straight seal side of the primary pouch, which if used could… Recall began Aug. 18, 2026
• Oct. 14, 2026Sperm Ab ELISA…Class IIPotential for false negative patient results. Recall began July 2, 2026
• Oct. 14, 2026Battle Bandage…Class IICompression bandage may be degraded, which may cause unwanted foreign material to be introduced inside the wound, which may lead to wound exploration… Recall began Sept. 2, 2026
• Oct. 7, 2026Lior brand Cinnamon Ground Seasoning…Class IIProduct contains elevated levels of lead.
• Oct. 7, 2026CHARLOTTE CLAW Screw…Class IIScrews, intended for use with polyaxial compression plating system intended for foot osteotomies, was manufactured with missing threads on the… Recall began Aug. 18, 2026
• 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, 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, 2026Philips EPIQ Elite Diagnostic Ultrasound System Model # 795234Class IIDue to software issue with ultrasound system, doppler sample is displayed shallower than its actual measurement location, potentially causing… Recall began Aug. 7, 2026
• Sept. 30, 2026INCA (Infant Nasal Cannulae Assy) Infant Nasal CPAP… and 1 more productClass IPotential to exhibit a loose connection between the flexible tubing and the nasal cannula, during assembly or while in use, which may result in loss… Recall began Aug. 11, 2026
• Sept. 25, 2026Sempio Food Services Inc. Recalls Ready-To-Eat Chicken Stew Products Imported Without the Benefit of Import…Class IImport Violation
• Sept. 23, 2026Hexing Haw Balls candy…Class IIIUnapproved dye Ponceau 4R
• Sept. 23, 2026Buckhead…Class IIThe Firm was notified by NJ Department of Health of two samples collected from tuna with reported high levels of scombrotoxin. Recall began July 24, 2026
• Sept. 23, 2026Martina brand Fresh Whole Mangoes…Class IIProduct may be contaminated with Salmonella Recall began Aug. 19, 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, 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, 2026Crown Farms Dried Suri Cut…Class IThe firm imported and distributed dried ribbon fish that was not properly eviscerated prior to drying. Recall began Aug. 1, 2026
• Sept. 16, 2026MedicaLyte Liquid Bicarbonate Concentrate REF: BC-100 and BC+201 and 3 more productsClass IIHemodialysis concentrates contain high endotoxin levels Recall began Aug. 5, 2026
• Sept. 16, 2026HeartSine SAM 350P 350P US Device…Class IIDue to a damaged (over stretched) membrane tail that causes an intermittent fault. Recall began July 27, 2026
• Sept. 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, 2026OLA-OLA Pounded Yam (Iyan) IYANINSTANT…Class IUndeclared milk. Recall began July 6, 2026
• Sept. 9, 2026Wonton Specialist Inc. Pan Fried Noodle… and 5 more productsClass IIIUndeclared FD&C Red No. 40 Recall began July 28, 2026
• 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, 2026Velys Enabling Tech Robotic-Assist Station REF: 451611001Class IISoftware issue within robotic controller which may cause unintended movement of the robotic arm during bone preparation or instrument positioning. Recall began July 23, 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. 9, 2026STA Staclot Protein S…Class IIA positive drift in QC values within the reagent's stated 4-hour onboard stability period was identified Recall began July 29, 2026
• Sept. 6, 2026Prime Line Distributors, Inc. and Ferrarini USA, Inc. Recall Imported Ready-To-Eat Pork Guanciale Products…Class IProduct Contamination
• Sept. 2, 2026Mehadrin Chocolate Leben…Class IIProduct may have been improperly pasteurized.
• Sept. 2, 2026Byron White FORMULAS A-L Complex Herbal Supplement 1.0 fl… and 2 more productsClass IILabel does not declare walnuts in English
• Sept. 2, 2026ERIDANOUS GREEK STYLE Shortbread Cookies with Chocolate Truffle… and 1 more productClass IIThe firm discovered that certain units shipped to the U.S. retail stores only has "foreign languages" on the label. Product has undeclared wheat… Recall began July 22, 2026
• Sept. 2, 2026Outshine Fruit Bars Strawberry… and 5 more productsClass IIForeign object: products may contain glass pieces
• Sept. 2, 2026Glutinous Rice Balls with Black Sesame Filling… and 1 more productClass IUndeclared peanuts. Recall began July 13, 2026
• Aug. 26, 2026VITASIA ASIAN STYLE WOK SPICE MIX…Class ISalmonella. The firm received a positive test result of Salmonella in the product.
• Aug. 26, 2026Prospector Popcorn Chocolate Mocha Gourmet Popcorn 1.5 oz and 3 more productsClass IIInaccurately declared nutrients including Carbohydrates (understated) and Cholesterol (understated). Recall began July 15, 2026
• Aug. 26, 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, 2026Fort Defiance Industries (FDI)…Class IIThe Automated Field Steam Sterilizer's water recovery system 120V Amphenol connector may experience an intermittent loss of ground continuity, which… Recall began July 8, 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, 2026Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen… and 1 more productClass IISyphilis Screen assay may contain a negative patient bias resulting in low reactive patient results being reported as nonreactive. Recall began July 13, 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, 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, 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, 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, 2026Pumpkin Tree Peter Rabbit Organics Banana & Strawberry fruit puree…Class IIPossible foreign object (thin, soft plastic strands). Recall began July 13, 2026
• Aug. 12, 2026Sliced Korean Halibut with Soy sauce… and 1 more productClass IIForeign Manufacturer label contains Undeclared allergen ingredients Wheat, Soy, Sesame, Yellow #5 and Blue #1 in Frozen Flounder Products. Recall began July 1, 2026
• Aug. 12, 2026"***Hondashi 0.25oz***" seasoning packed in silver plastic/metallic pouch…Class IIAllergen missing from contains statement: fish Recall began July 9, 2026
• Aug. 12, 2026Neuroguard 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 due to a wire-to-filter-bond… Recall began June 29, 2026
• Aug. 12, 2026Brand Name: COAPTIUM Connect Product Name: COAPTIUM Connect… and 7 more productsClass IICurrently labeled shelf life of 36 months is not substantiated by real-time data. Devices will be relabeled to reflect revised shelf life of 26… Recall began June 15, 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, 2026Happiest Baby…Class IIThis recall is retroactively being reported. Refurbished bassinets failed to meet quality standards prior to distribution. Recall began May 15, 2024
• 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, 2026DQ Chocolate Reduced Fat Ice Cream Mix…Class IIForeign material found in product (identified as metal shavings) Recall began May 21, 2026
• 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, 2026OsteoBallast…Class IIDemineralized bone matrix (DBM) in resorbable mesh indicated for use with autograft as a bone graft extender in the posterolateral spine and pelvis… Recall began July 2, 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, 2026M5 Corpus Power Wheelchair REF,120032Class IIThis recall is being reported retroactively. Power Platform firmware is missing specific drive inhibit logic. This issue may allow the chair to drive… Recall began June 19, 2025
• 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, 2026Permobil M3 Corpus Power Wheelchair with Heavy Duty Shock REF:120031…Class IIThis recall has been reported retroactively. The power wheelchair firmware lacks a speed restriction to maintain stability when the seat lift exceeds… Recall began Feb. 29, 2024
• 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, 2026Brooklyn Roasting Company Pasteurized Cold Brew Concentrate…Class IIAmbient storage of the product may lead to Clostridium botulinum toxin formation.
• 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, 2026Emano Flow with software version v2.0.0 GS1 GTIN code: 199874903484 Emano Flow is a smartphone-based acoustic…Class IIProblem description/Reason for recall: During the period March 22, 2026, to May 29, 2026, recorded urination audio was captured at 48,000 Hz while… Recall began May 29, 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, 2026Penumbra System RED 68 Reperfusion Catheter REF: RED68KITClass IIDue to manufacturing issues, reperfusion catheters may fractures Recall began June 3, 2026
• July 29, 2026Olympus 4K UHD LCD Monitor…Class IIPotential for the HDMI and DisplayPort (DP) connectors can become faulty resulting in image loss or image abnormalities.
• July 29, 2026Power F2 Powered Fastening System…Class IIProduct may experience accelerated roller wear and potential deformation due to interference between the roller assembly and rail. In the worst-case… Recall began June 19, 2026
• July 29, 2026MEDLINE ANTERIOR HIP… and 2 more productsClass IMedline Industries, LP is issuing a recall for specific Medline kits containing B. Braun convenience kits that include Bupivacaine Hydrochloride in… Recall began June 5, 2026
• July 22, 2026Ruby…Class IIForeign material (Glass) was found in the product. Recall began May 15, 2026
• July 22, 2026Amy's ORGANIC SOUPS LENTIL LIGHT IN SODIUM…Class IIPotential for spoilage. Recall began June 22, 2026
• July 22, 2026Ice Pop… and 15 more productsClass IMay contain undeclared milk, pecans, pistachios, yellow #5 and red #40. Recall began May 4, 2026
• July 22, 2026WY Duck Sauce…Class IIProduct may contain metal fragments. Recall began June 4, 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 15, 2026Wise Onion Rings…Class IIThe product contains undeclared Yellow 5 and 6, Blue 1, and unapproved Red 3. Recall began May 28, 2026
• July 15, 2026TMINI Femur Tracking Array REF 109003 UDI-DI code: M9461090030 TMINI Tibia Tracking Array REF 109004 UDI-DI…Class IIDue to manufacturing/design issue where the knob on the tracking array may loosen causing potential misalignment of the array. Recall began May 8, 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, 2026Bosco's Blend Chicken Doggone Raw Net Weight 2 lbs and 10 lbs Frozen…Class IPotential Salmonella contamination
• 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, 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: Medela Product Name: ENFit ExSet Strl 60 2.0ml PV 1ct EN Model/Catalog Number: ENF060182LD /…Class IIMay contain incorrect connectors and will not attach or misconnect to ENFit connections and is thus incompatible. Issue could lead to slight delay in… Recall began June 5, 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, 2026Medline Convenience kits containing recalled Swan-Ganz Catheters… and 7 more productsClass IIKits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue)… Recall began May 28, 2026
• July 8, 2026Breathing circuit set…Class IVentilator coaxial breathing circuit may have, expiratory valve sets with membranes sticking to valve body, not detectable during pre-operative test… Recall began May 29, 2026
• July 1, 20266/11oz Sunflower Seeds Salted and 5 more productsClass IThe firm is recalling sunflower seed products due to the presence of an undeclared tree nut allergen, cashew. Recall began April 29, 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, 2026El David Gelee…Class IIUndeclared colors (FD&C Yellow 5 and FD&C Red 40). Recall began May 21, 2026
• July 1, 2026Joy Mango Lassi 16 oz… and 13 more productsClass IIProduct not adequately pasteurized Recall began April 23, 2026
• July 1, 2026Abiomed 14 Fr x 13 cm Low Profile Introducer Kit for Impella CP… and 3 more productsClass IPotential for thrombus formation during prolonged use of the introducer. Recall began May 22, 2026
• 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, 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, 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 25, 2026Reser’s Fine Foods, Inc. Recalls Ready-To-Eat Pasta Salad Product Due to Misbranding and Undeclared AllergensClass IMisbranding; Unreported Allergens
• 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, 2026TRI TS BASEPLATE SIZE 3… and 1 more productClass IIStryker has identified that Triathlon Universal Baseplate Size 3 (lot UZD9IB), is contained in packaging labeled as Triathlon Universal Baseplate… Recall began May 19, 2026
• 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, 2026Farm Rich Pizza Cheese CrunchersClass IIMay contain metal pieces
• June 17, 2026WeiKFiELD Custard Powder Kesar Pista…Class IIIThe ingredient, Pista, currently declared on our label should be corrected to the standard American nomenclature, Pistachio. Recall began Feb. 25, 2026
• June 17, 2026MOSAIQ Oncology Information SystemClass IISoftware may fail to load adapted baseline shift plan during treatment delivery when a communication error occurs.
• 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, 2026NeoSpan SuperElastic Compression Staple w/Instruments Catalog Number and Product Name T50 SN010 NeoSpan…Class IIDue to the Magnetic Resonance Conditional Symbol missing on the carton, inner tray, and patient label. Recall began May 11, 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 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, 2026Birch Benders Sweet Potato Pancake and Waffle Mix 12oz bag…Class IUndeclared egg
• June 10, 2026Betaine Anhydrous…Class IIPossible carbon steel foreign material (1-2mm) Recall began Dec. 15, 2025
• June 10, 2026Hellas Meze Golden Smoked Whole HerringClass IUn-eviscerated fish may be contaminated with clostridium botulinum
• June 10, 2026STRAUS FAMILY CREAMERY Vanilla Bean ORGANIC SUPER PREMIUM ICE CREAM… and 4 more productsClass IIPotential contamination with foreign objects (metal pieces).
• 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, 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, 2026PhaseOne Antimicrobial Solution…Class IIThe recall is being conducted due to corrosion of the internal metallic spring within the sprayer component. This condition is caused by material… Recall began April 27, 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, 2026Ivenix Infusion System (IIS)…Class IFresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components… Recall began May 6, 2026
• June 10, 2026LVP software of the Ivenix Infusion System (IIS)…Class IPotential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that… Recall began May 6, 2026
• June 3, 2026Wawa Iced Tea Lemon 16 oz Pint… and 3 more productsClass IUndeclared Milk Allergen, Recall began April 2, 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
• May 31, 2026Synear Foods USA, LLC Recalls Frozen Pork and Crab Soup Dumpling Products Due to Misbranding and Undeclared…Class IMisbranding; Unreported Allergens
• May 27, 2026GHIRARDELLI PERFECTLY PREMIUM FRAPPE MIX FROZEN HOT COCOA… and 9 more productsClass IPotential contamination with Salmonella. Recall began April 26, 2026
• 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, 2026Uncle Giuseppe's Marketplace Milk Chocolate Bridge Mix…Class IIContains undeclared allergens (cashews, milk, and soy). Recall began April 20, 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, 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 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 4, 2026FSIS Issues Public Health Alert for Ravioli Pasta With Beef Sauce Due to Misbranding and Undeclared AllergensMislabeling; Unreported Allergens
• April 29, 2026Spice Powder…Class IILead level was higher than NYSAGM Standard. Recall began Oct. 17, 2024
• April 29, 2026Bombay Kitchen brand Tikka Sev… and 1 more productClass IIProduct(s) contain undeclared colors, FD&C Yellow #6 and FD&C Red #40 Recall began March 25, 2026
• April 29, 2026Diversatek Healthcare Viper 3-Stage Fixed Wire Balloon Dilator… and 3 more productsClass IIThe catheter inflation tag attached to the device may contain an incorrect part number with incorrect balloon diameter sizes and inflation pressures… Recall began March 18, 2026
• April 29, 2026Rover Mobile X-ray System Model/Catalog Number: MXU-RV35 and MXU-RV71Class IIX-Ray generator may malfunction resulting in the X-Ray being inoperable. Recall began March 27, 2026
• April 22, 2026Label is predominantly green with white lettering in a clear plastic clamshell container…Class IImislabeled Coconut Date Bites. (product is coconut covered, label is for regular date bites)
• 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, 2026Cytal Wound Matrix 2-Layer 5x5 cm… and 4 more productsClass IIIncreased rate of out-of-specification endotoxin results. Recall began March 19, 2026
• April 22, 2026Instinct Plus Endoscopic Clipping Device REF: G58010 Rx Only…Class IIDue to increased in complaints their is the potential for endoscopic clipping device to malfunction. Recall began March 3, 2026
• April 22, 2026iLet Ace Pump Kit REF: BB1001 iLet Dosing Decision SoftwareClass IIit was found that in versions 1.3.7, 1.4.2, and 1.4.3, the Lock Screen and Limited Access Passcode Screen on the iLet graphical user interface (GUI)… Recall began Aug. 13, 2025
• April 15, 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, 2026Crab Cakes various sizes sold to food serviceClass IIMay be temperature abused, which may result in growth of Clostridium botulinum
• April 15, 2026Boner Bears Honey Male Enhancement 100% Wildflower Honey… and 2 more productsClass IFDA analysis revealed the presence of undeclared sildenafil and Tadalafil Recall began March 13, 2026
• 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, 2026Multi-parameter Command Module…Class IIMulti-parameter command module has a circuit board issue and when in Auto mode, Cardiac Output (CO) measurement may activate early, resulting in Bad… Recall began Feb. 27, 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 9, 2026FSIS Issues Public Health Alert for Beef and Pork Products Due to Misbranding and Undeclared AllergenMisbranding; Unreported Allergens
• 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, 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, 2026Brand Name: Finesse BTK Multicath Product Name: Injectable Angioplasty Balloon Catheter Model/Catalog Number…Class IIPotential for the balloon in the device to not meet burst specifications. Recall began July 21, 2025
• April 8, 20262.4 VOLT TAP LOCKING SCREW TAP TO 90MM… and 1 more productClass IIA full lot swap between VOLT Locking Screw Tap 03.424.124 lot 68900P9 and Cortical Screw Tap 03.424.126 lot 68982P8, resulting in the bones taps… Recall began Feb. 25, 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 8, 2026BD Kiestra" ReadA…Class IIIn certain situations, following a system reboot, one or more modules may have become unreachable via the remote connectivity interface. When this… Recall began Feb. 6, 2026
• April 8, 2026RefleXion X1 Radiotherapy System Model RXM1000…Class IIDue to a radiotherapy medical system software defect, when performing angular roll corrections followed by a repeat localization, the roll… Recall began Feb. 9, 2026
• April 1, 2026Favorina Chocolate Ladybugs German-Style Nougat…Class IILabel does not specify type of tree nut contained in the product.
• April 1, 2026Basil Pesto & Mozzarella Pizza… and 1 more productClass IIMetal fragments in bread. The firm discovered metal fragments in various bread products. They determined the cause to be roasted tomatoes provided by… Recall began Jan. 19, 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: TECNIS Eyhance IOL with TECNIS Simplicity" Delivery System Product Name: TECNIS Eyhance IOL with…Class IIDue to identifying a limited quantity of intraocular lenses that may have a haptic that sticks to the optic which prevents the lens from unfolding as… Recall began Feb. 19, 2026
• 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, 2026Wawa Reduced Fat Milk 2% 16 oz (Pint) and 3 more productsClass IIForeign plastic material discovered on fill line. Recall began Feb. 17, 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, 2026VEGETARIAN CHICKEN FLAVOR RAMEN Express… and 1 more productClass IIProduct contains undeclared Yellow #5 Recall began Jan. 17, 2026
• March 18, 2026C2O Coconut Water with Pulp (17.5 oz) 15 Pack…Class IIIThe outer cardboard box for the canned coconut water has the incorrect Nutrition Facts Panel and Ingredient List, which does not include added sugar…
• 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, 2026DxC 700 AU… and 1 more productClass IIA delay in results may occur. When clinical chemistry analyzer calibration monitor with PC installed with Microsoft SQL Server 2022 Express is open… Recall began Jan. 30, 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, 2026Endo-Model SL Connection Component incl… and 12 more productsClass IIThe potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Recall began Jan. 12, 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, 2026VERGANI 1944 MILANO 'PANDORO CLASSICO' Gluten Free…Class IIPotential contamination with foreign material (Teflon fragments) from flaking cooking molds.
• March 11, 2026Premium Food Jordan Almonds… and 1 more productClass IIContains undeclared allergen (wheat) and colors (FD&C Blue 1 Lake and FD&C Blue 2 Lake). Recall began Jan. 16, 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: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF)…Class IIThe potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects… Recall began Feb. 4, 2026
• 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, 2026Fish Ball… and 2 more productsClass IUndeclared allergen ingredient (Wheat and Sesame) Recall began Jan. 28, 2026
• March 4, 2026Prime Food Processing Dried Croaker Fish…Class IUneviscerated Fish
• March 4, 2026Campy CVA Medium 100/PK…Class IICustomer complaints report low to no recovery of Campylobacter Jejuni ATCC 33291 on identified lot of medium.
• 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, 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. 25, 2026MediHoney Gel with Active Leptospermum Honey… and 2 more productsClass IIPotential packaging failures, which could lead to a breach in the sterile barrier. Recall began Jan. 16, 2026
• Feb. 18, 2026Karison brand BESAN LADDOO… and 4 more productsClass IIProduct contains milk, which is undeclared in the ingredient statement. Recall began Jan. 6, 2026
• 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, 2026Kirkland Signature Costco item #1181272 Mini Beignets filled with Caramel 22CT…Class IUndeclared hazelnut.
• 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, 2026Halyard TRANSPORT BAG KIT…Class IITyvek bag seal issue which may compromise sterility of the kit. Recall began Jan. 2, 2026
• 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, 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, 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, 2026Brand Name: Da Vinci Product Name: da Vinci X…Class IIDue to a software implementation error that allowed instruments arms failing an important diagnostic test to remain in clinical use. This test was… Recall began Nov. 7, 2025
• 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, 2026Conductivity Standard Solution Catalog/Model Numbers: 10001…Class IIdue to a defect associated with the conductivity values of the solution used to calibrate meters and result in the reporting of incorrect… Recall began Dec. 12, 2025
• Feb. 4, 2026PearMatrix P-15 Peptide Enhanced Bone Graft Bone Graft…Class IIIncorrect expiration date Recall began Dec. 29, 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, 2026Brussel Sprouts & Kale SlawClass IUndeclared Fish and Egg Allergen
• Jan. 21, 2026Shrimp Paste (Klong Kone) 'M'… and 1 more productClass IIProduct tested high for lead. Recall began Nov. 19, 2025
• Jan. 21, 20262248 Banana Pudding Ice Cream… and 1 more productClass IIUndeclared soy lecithin Recall began Dec. 12, 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, 2026Ivenix Infusion System (IIS)…Class IIEmphasizing instructions for LVP duration programming located in the IFU. Recall began Nov. 21, 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, 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, 2026Sapori Amaretti Almonds 175 g CookiesClass IIContains elevated levels of hydrocyanic acid Recall began Dec. 14, 2025
• 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, 2026The Pressio 2 ICP Monitoring System…Class IICustomer complaints of Pressio monitor rebooting. Recall began Nov. 17, 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. 14, 2026The Elecsys Anti-TSHR immunoassay is a three-step competitive immunoassay with streptavidin-coated…Class IIIssues identified: 1) Results vary by Instrument Platform; 2) Calibrator Lot-to-Lot Variability. Issues may lead to delayed or incorrect diagnosis… Recall began Nov. 21, 2025
• Jan. 7, 2026Philips EPIQ Ultrasound Systems (various models) used in conjunction with the X5-1c transducer REF…Class IIRetroactive: Ultrasound may experience an unexpected automatic reboot, resulting in damage to transducer. Recall began July 14, 2022
• Dec. 31, 2025Locatelli Pecorino Romano Cheese Grated (Wegmans #270010) Packaged and sold by the pound Packaged in…Class IProduct may be contaminated with Listeria monocytogenes. Recall began Nov. 22, 2025
• Dec. 31, 2025Ritz Peanut Butter Cracker Sandwiches…Class IIUndeclared allergens (Peanut) due to mispackaging Recall began Nov. 28, 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, 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, 2025SENNA LEAVES F/C OG Item No: SEN15001…Class IPotential contamination with Salmonella. Recall began Nov. 21, 2025
• Dec. 24, 2025Belevini KORUSHKA… and 1 more productClass IClostridium botulinum (uneviscerated fish) Recall began Oct. 27, 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, 2025Brand Name: Xpert BCR-ABL Ultra Model/Catalog Number: GXBCRABL-US-10 and 1 more productClass IIInvitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results. Recall began Oct. 30, 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, 20251ml of DTT in liquid phase… and 1 more productClass IITreatment reagent functionality in respiratory specimens liquification cannot be guaranteed. Recall began Oct. 29, 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, 2025Orthofix NorthStar OCT Navigation Surgical Technique Guide…Class IIThe NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards… Recall began Nov. 17, 2025
• Dec. 24, 2025Ivenix Infusion System (IIS)…Class ISoftware version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. Recall began Nov. 14, 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, 2025Doughy brand Chocolate Chip Cookie Dough…Class IProduct may be contaminated with Salmonella
• Dec. 17, 2025Hemodialysis System…Class IIScrew may loosen or fallout of Hemodialysis system Recall began Oct. 27, 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, 2025Italian Salad Dressing… and 1 more productClass IIforeign objects (black plastic planting material) in granulated onion Recall began Nov. 6, 2025
• Dec. 10, 2025Loaded Veggie Grain Bowl…Class IIPotential contamination with Listeria monocytogenes. Recall began Oct. 7, 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, 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, 2025Organic Moringa Leaf Powder (Moringa Powder)…Class IProduct tested positive for Salmonella. Recall began Nov. 4, 2025
• Dec. 10, 2025Reagent Kits/ containing flow cells…Class IIAn instrument intended for sequencing DNA libraries with in vitro diagnostic assays is used with reagent kits including flow cells that have flow… Recall began Oct. 28, 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, 2025Hemochron Activated Clotting Time Low-Range Test Cuvette…Class IITest cuvettes, used with an assay for monitoring heparin anticoagulation, may have a foreign object that has sharp edges and could pose a risk of… Recall began Nov. 5, 2025
• Dec. 10, 2025Phantom Fibula Nail…Class IIFibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so… Recall began Oct. 13, 2025
• Dec. 10, 2025Ivenix Infusion System (IIS)…Class IIDownstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set. Recall began Nov. 3, 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, 2025Nat's Nuts Cinnamon Whiskey Pecans…Class IIContains undeclared cashews Recall began Oct. 16, 2025
• Dec. 3, 2025IntelePACS…Class IISoftware application that receives digital images and data to be communicated, processed, manipulated, enhanced, stored, displayed has a bug that… Recall began Oct. 17, 2025
• 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, 2025Sevoflurane (SEVO) V90 Electronic Vaporizer with the A9 Anesthesia… and 1 more productClass IIPotential for anesthesia leakage. Recall began Oct. 20, 2025
• Dec. 3, 2025BioFire Respiratory Panel 2.1…Class IIDue to unintended movement of pouch chemistry, nucleic acid test may result in elevated risk of false negative results and risk of control failures. Recall began Oct. 22, 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, 2025CONSTELLATION ULTRAVIT 10K and CONSTELLATION HYPERVIT 20K…Class IIXXX Recall began Sept. 15, 2025
• Dec. 3, 2025FoundationOne CDx (F1CDx)… and 1 more productClass IIReports were sent to customers without the companion diagnostic (CDx) Claims Page. Claims pages were distributed via amended reports within 7 days of… Recall began Nov. 8, 2022
• Nov. 26, 2025Bulk and Organic Organic Moringa Powder…Class IPossible Salmonella Richmond
• Nov. 26, 2025Dry Ghoinnya FishClass IUn-eviscerated fish may be contaminated with Clostridia botulinum.
• 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, 2025Meridian Bioscience… and 1 more productClass IIThe cap on the reaction buffer tube may be missing the black rubber gasket resulting in the potential for leakage and reduced buffer volume. Recall began Oct. 7, 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. 19, 2025Product Name: Nutra Calm Package: 175cc HDPE Bottle… and 2 more productsClass IIProducts contains Magnesium Salicylate. Recall began June 18, 2025
• Nov. 19, 2025Loaded Veggie Grain Bowl…Class IIPotential contamination with Listeria monocytogenes Recall began Oct. 7, 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, 2025BD Kiestra" Isolate Suspension Cuvette Array…Class IIThe 2D barcodes on these cuvettes contain formatting errors that prevent the analyzing system from correctly reading the expiration date. As a…
• Nov. 19, 2025SimplyGo Mini…Class IICertain serial numbers of the SimplyGo Mini standard battery kit contain a defective chip which can lead the battery to either fail to charge or lose… Recall began Oct. 7, 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, 2025Lucky Foods Cinnamon Powder…Class IIProducts may contain elevated levels of lead.
• Nov. 12, 2025Eagle Spice Ground Ginger 16 ozClass IIContains elevated levels of lead (Pb) Recall began Oct. 7, 2025
• Nov. 12, 2025Dr. Praeger's…Class IIProduct was made on equipment that test positive for Listeria . Recall began Sept. 22, 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, 2025Fusia Asian Inspirations brand Veggie Spring Rolls…Class IUndeclared shrimp
• Nov. 5, 202547518 - Nonpareil, Semi-Sweet Chocolate (Christmas Seeds), 25lb Bulk… and 1 more productClass Iundeclared milk allergen Recall began June 16, 2025
• Nov. 5, 2025HADLIMA (adalimumab-bwwd) injection…Class IILack of Assurance of Sterility.
• 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, 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, 2025Assay: IMMULITE 2000 Intact PTH…Class IIThe potential for falsely depressed Intact PTH patient results at the low end of the assay range, less than or equal to 50 pg/mL (less than or equal… Recall began Sept. 22, 2025
• Nov. 5, 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, 2025SuRgical Planner (SRP)… and 6 more productsClass IIA software anomaly, under specific conditions when large rotational alignment values are applied in 2D Image Fusion, may lead to misalignment of any… Recall began Sept. 16, 2025
• Nov. 5, 2025Magseed Pro 7 cm soft tissue marker… and 1 more productClass IIPotential for contamination with cotton fibers. Recall began Oct. 1, 2025
• Nov. 5, 2025Brand Name: Alcon Laboratories… and 4 more productsClass IIDue to incomplete seals in the pouch which provide the sterile barrier. Recall began Aug. 5, 2025
• Oct. 29, 2025Twin Marquis brand THICK SHANGHAI STYLE PLAIN NOODLE…Class IProduct contains undeclared egg, FD&C Yellow 5, and FD&C Yellow 6.
• 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, 2025Ben's Original Ready Rice Long Grain & Wild… and 2 more productsClass IIPossible presence of stones in product Recall began Sept. 12, 2025
• Oct. 29, 2025Sprouts Smoked Mozzarella Pasta Salad…Class IProduct may contain Listeria monocytogenes.
• Oct. 29, 2025Floria Dried Apricots…Class IProduct contains undeclared sulfites. Recall began April 29, 2025
• Oct. 29, 2025Sedecal Mobile Digital Diagnostic X-Ray Systems… and 45 more productsClass IISedecal sent an email to its consignees to remind the users that the equipment is not water-resistant and must be cleaned strictly according to the… Recall began June 10, 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, 2025iNSitu Bipolar Hip System…Class IIDownstream recall for RES 97605, BioPro femoral components. Product failed transit testing. Impacted product may have potential issues with sterile… Recall began Sept. 11, 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, 2025Raw Bistro Dog Fare Grass-Fed Beef Entree…Class IPotential Salmonella contamination.
• 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, 20251. SILVER HORSE…Class IIContains elevated levels of lead Recall began Sept. 18, 2025
• Oct. 22, 2025Wawa HVD (Whole) Milk… and 2 more productsClass IIPotential foreign object contamination
• Oct. 22, 2025Haifa COLD SMOKED SALMON 8 OZ and 1 more productClass IContaminated with Listeria monocytogenes Recall began Sept. 17, 2025
• 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, 2025Cyclopen Microinterventional Cyclodialysis System… and 1 more productClass IIPotential for compromised integrity of the sterile packaging. Recall began Sept. 6, 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, 2025Toto S'Mores Ooey Gooey Cookie…Class IIProduct label contains conflicting statements about inclusion and being free of Soy ingredient. Recall began Aug. 20, 2025
• Oct. 15, 2025Organic BABY bedtime drops…Class IIPotential yeast contamination. Recall began Sept. 12, 2025
• Oct. 15, 2025PINOCCHIO CATERING Aged Kimchi Mackerel…Class IProduct contains undeclared milk and shrimp Recall began Sept. 8, 2025
• 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, 2025Taproom Gourmet brand 20lb and 18lb bulk "Fifth Avenue" Mix and 4 more productsClass IINo ingredient label. Product contains undeclared allergens (peanuts, almonds, cashew, and soy)
• 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, 2025ClariTEE Miniaturized TEE probe…Class IIProduction assembly error resulting in the potential for reversed articulation, where moving the lever forward caused the probe tip to anteflex… Recall began Aug. 29, 2025
• Oct. 8, 2025Goot Essa…Class IThe firm had a positive Listeria Monocytogenes on a sample from this batch of product made.
• Oct. 8, 2025vitamins B12 dietary supplement Raspberry Flavored sold under the following brand names: 1…Class IIUndeclared Peanuts. The firm was notified by their supplier, that the product may contain undeclared peanuts. Recall began June 13, 2025
• Oct. 8, 2025ZAP-X Radiosurgery System…Class IIIf the radiosurgery system triggers a proximity error message during a long gantry move (greater-than180 degrees), and a subsequent proximity error… Recall began July 25, 2025
• 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, 2025Sterile Medline Convenience Kits: 1) MAJOR PACK L-F… and 1 more productClass IConvenience kits labeled as sterile have not gone through the sterilization process. Recall began Aug. 8, 2025
• Oct. 8, 2025GORE ACUSEAL Vascular Graft…Class IIReports of vascular graft delamination, which may lead to reduced access flow; cannulation difficulties; bleeding or bruising; and harms related to… Recall began Aug. 26, 2025
• Oct. 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, 2025NES Reprocessed 0.9mm OTW Turbo Elite Laser Atherectomy Catheter… and 7 more productsClass IIPotential for breaches in the sterile barrier packaging, compromising sterility assurance. Recall began Aug. 29, 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. 1, 2025GOODLES VEGAN IS BELIEVIN' PLANT-BASED WHITE CHEDDAR WITH SPIRALS… and 1 more productClass IUndeclared allergens (milk).
• 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, 2025Endico brand MIXED VEGETABLES… and 1 more productClass IProduct may be contaminated with Listeria monocytogenes.
• Sept. 24, 2025(Bulk) Oyster…Class IIOyster product potentially contaminated with Norovirus Recall began Aug. 7, 2025
• Sept. 24, 2025Cucumbers Peeled/Dice 1/4" KBS 5LB… and 4 more productsClass IProduct contaminated with Salmonella Recall began May 20, 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, 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, 2025Organic BABY bedtime drops…Class IIPotential for spoilage due to yeast contamination. Recall began Aug. 5, 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, 2025Duloxetine Delayed-Release Capsules…Class IICGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit. Recall began Aug. 8, 2025
• Sept. 17, 2025TiBrid Stand Alone Intervertebral Body Fusion Device… and 1 more productClass IIFailure of fusion system instruments in the field. Recall began July 15, 2024
• Sept. 17, 2025Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID… and 3 more productsClass IIThe reamer may kick or bind up during or immediately prior to use. Recall began July 18, 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, 2025LinkSymphoKnee System…Class IISome modular LinkSymphoKnee TiNbN Tibial Components were manufactured with two uncoated security screws, which is incorrect. Recall began July 31, 2025
• 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. 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, 2025Evergreen Farm Korean Pear Juice… and 2 more productsClass IILack of pasteurization and sanitation records Recall began July 3, 2025
• Sept. 10, 2025Nirwana Foods…Class IIUndeclared Sulfites in product Recall began June 23, 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, 2025Interventional Fluoroscopic X-Ray System…Class IIPotential that a component (air baffle) may be missing in some Nehalem FlexVision-2 PCs that are part of the Allura Xper series. Recall began Aug. 1, 2025
• Sept. 10, 2025RefleXion X1 Model RXM1000 UDI Codes: (01)00860003983812(11)230504(21)X11001…Class IIDue to incorrect software configuration that potentially allows more than two (2) fractions within a 12-hour period (fractionLimits) and could… Recall began July 22, 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, 2025Viva for Dogs Ground Chicken Complete Dog Food… and 5 more productsClass IPotential Salmonella contamination.
• 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, 2025Deep Sprouted Mat 16 oz and 1 more productClass IProduct tested positive Salmonella . Recall began June 28, 2025
• Sept. 3, 2025Baker's Authority Three Seed Mix… and 2 more productsClass IIProduct label does not list ingredients including major food allergen: sesame. Additional undeclared ingredients include: millet and flax
• 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, 2025IPC Powerease System REF 2300000 UDI-DI: 00613994448705 00643169406834…Class IIDue to out of the box wobble of the driver. Recall began July 17, 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, 2025Dynex Agility Sample Tips…Class IIThe internal label affixed to the sample tip rack is incorrectly labeled as reagent tip racks. When scanned by the Agility instrument, the tip rack… Recall began July 16, 2025
• Aug. 27, 2025Burr Hole Cover Kit…Class IIResistance and difficulties could occur while closing the retaining clip locking mechanism, which is part of a burr hole cover kit, which is part of… Recall began July 8, 2025
• Aug. 27, 2025Pentax Medical Video Processor…Class IIDuring endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become… Recall began July 16, 2025
• Aug. 20, 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, 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, 2025a.) Actylis brand Lithium Orotate 4% packaged in HDPE Liner in a 25kg carton b.) Actylis brand Lithium…Class III4% Lithium Orotate product may only contain 3% and 9% Lithium Orotate product may contain 4.45% Recall began June 24, 2025
• Aug. 20, 2025Duloxetine Delayed-Release Capsules…Class IICGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.
• 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, 2025Prosthesis Head B… and 1 more productClass IIInconsistent size terminology and color coding used on labeling Recall began July 15, 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. 20, 2025DreamStation Auto CPAP… and 2 more productsClass IDevices may possess a programming error resulting in an incorrect device configuration. Recall began June 30, 2025
• Aug. 13, 2025Member's Mark FREEZE DRIED FRUIT VARIETY PACK 15 COUNT 5-0.35OZ (10g) STRAWBERRY POUCHES 5-0.42OZ (12g)…Class IListeria monocytogenes. During routine testing the firm received positive test results for Listeria monocytogenes.
• Aug. 13, 20251) OH MMB Human Donor Milk…Class IIInaccurate temperature reading from a thermometer on one pasteurization machine Recall began July 14, 2025
• Aug. 13, 2025Favorite Day Bakery Frosted Sugar Cookies…Class IIForeign Material (wood)
• Aug. 13, 2025FANCY MEDIUM PECAN PIECES 81124 561958 554707 6/13/2025 SDC1645 90 FANCY MEDIUM PECAN PIECES 81124 561965…Class IPecans have the potential to be contaminated with Salmonella, Recall began July 10, 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, 2025IontoPatch STAT… and 1 more productClass IIThe nonwoven pads in the device do not absorb the saline solution or any other liquid intended to be used with the device. Recall began May 22, 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, 2025The Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store…Class IIThe Drill stop kit contains incorrect components. Recall began May 1, 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
• July 30, 2025Acepromazine Maleate… and 1 more productClass IIProduct does not meet potency specifications.
• July 30, 2025Ritz Peanut Butter Cracker Sandwiches… and 3 more productsClass IIUndeclared allergens (Peanut) due to mispackaging
• July 30, 2025Stryker… and 1 more productClass IIDue to complaints their is the potential that irrigation solution may leaked into the handpiece and battery pack causing it to malfunction. Recall began June 18, 2025
• July 30, 2025ACUVUE OASYS MAX 1-Day MULTIFOCALClass IIDue to defects (bubbles/voids) identified during standard finished goods testing Recall began June 12, 2025
• July 30, 2025Bridge to Life EasiSlush…Class IIThe firm issued a field safety notice after becoming aware of three lots of products not having quarterly dose audits being completed on time in the… 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, 2025Calais Brand Grape jelly…Class IIIContains undeclared colors (FD&C Blue 1 and FD&C Red 40) Recall began Feb. 19, 2025
• July 16, 20251. USA APLS RED DEL TOTE 2… and 29 more productsClass IIMay be contaminated with fluid from a reach truck Recall began June 7, 2025
• July 16, 2025Wegmans brand Mini Muffins… and 2 more productsClass IIProduct may contain foreign objects of metal origin. Recall began June 14, 2025
• July 16, 2025Weaver Chocolates… and 1 more productClass IUndeclared Milk Allergen Recall began June 16, 2025
• July 16, 2025B Natural Organics… and 3 more productsClass IIcGMP deviations Recall began March 12, 2025
• July 16, 2025Brand Name: Alcon Laboratories… and 2 more productsClass IIDue to the potential that some units within specific lots were damaged during the manufacturing process. The area of damage is within the same area… Recall began April 28, 2025
• July 16, 2025Brand Name: Optisite Arterial Cannula Product Name: Optisite Arterial… and 5 more productsClass Idue to complaints received for 3mm to 4mm section wire exposed/protruding from the outside of the cannula body. Recall began May 14, 2025
• July 9, 2025King's All Stock Feed… and 4 more productsClass IElevated levels of fumonisin Recall began May 1, 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, 2025Pitavastatin Tablets… and 1 more productClass IIIFailed Impurities/Degradation Specifications.
• 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 9, 2025Change Healthcare Cardiology Hemo Software and 1 more productClass IIDue to complaints, software update may cause software to unexpectedly shutdown. Recall began May 22, 2025
• July 2, 2025Salted Smoked Split Herring…Class IClostridium botulinum (uneviscerated fish)
• 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, 2025TESTO-200…Class IIMarketed Without an Approved NDA/ANDA Recall began May 30, 2025
• July 2, 2025REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487…Class IIDue to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when… Recall began April 8, 2025
• July 2, 2025Product Name [REF]: Supply Server…Class IIDuring automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then… Recall began May 8, 2025
• July 2, 2025REF: 381423, BD Insyte Autoguard, Shielded IV Catheter, 22GA X 1.00… and 8 more productsClass IIDue to customer complaints, there is the possibility that catheter needle may be slow to retract or fail to retract. Recall began May 21, 2025
• July 2, 2025DxI 9000 Access Immunoassay Analyzer C11137Class IIAnalyzer has calibration issues where curves switched from passed to failed due to system errors during aspiration. This anomaly causes erroneous… Recall began May 7, 2025
• July 2, 2025Model: Description/REF: MNA-420: MNA-420 ENC -H/K9303320…Class IICathode ray tube display system encoders and decoders have same MAC address; new system setup with two or more affected units can lead to systems not… Recall began May 9, 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 25, 2025Biomet 3i Certain-compatible 4.1 mm Milled Ti Abutment REF 9001767-F Preat milled Abutments are intended to…Class IIDue to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter… Recall began April 2, 2025
• June 18, 2025Jean's Classy Fresh Salsa… and 7 more productsClass IProduct has Salmonella contamination
• 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, 2025iBOT PMD with software version 01.05.24…Class IISoftware issue that could potentially lead to the device tipping over from Balance Mode. Recall began April 24, 2025
• June 18, 2025Contamac…Class IIContact lens insertion solution may lack sterility. Recall began May 15, 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 18, 2025Long Nail…Class IIInvestigation confirmed that the GAMMA4 Right Long Nail was manufactured with the geometry of a left nail.
• June 18, 2025IVENIX INFUSION SYSTEM LVP Blood Products Administration Set…Class IMis-assembly error of Blood Products Administrations Sets where the 200-micron drip chamber filter may be incorrectly positioned and unable to filter… Recall began May 12, 2025
• June 11, 2025AMCE GREEK SALAD AUTHENTIC FS…Class ISalmonella. Greek Salad products were made with recalled cucumbers from Bedner Grower's Company which are contaminated with Salmonella and implicated…
• June 11, 2025Bengal King Family Pack Vegetable SingaraClass IContains undeclared peanut
• June 11, 2025Eudos BronquilanClass IIUndeclared colors (FD&C Yellow #5, FD&C Blue #1, and FD&C Red #40)
• June 11, 2025Cucumbers Pennrose Farms…Class IDue to potential Salmonella Contamination
• June 11, 2025GNC Women's 30+ Vitapak…Class IIIUndeclared Fish allergen (parvalbumin). Recall began April 25, 2025
• June 11, 2025Sample probe sucks a sample dispensed into a tube or cup and… and 1 more productClass IIA manufacturing defect in the sample probe (S probe). The corners of the tip of the defective S probe are rounded and chamfered, which can prevent… Recall began April 30, 2025
• June 11, 2025VERIGENE Gram Negative Blood Culture (BC-GN) Nucleic Acid Test…Class IIIt was determined that the consumable issue may result in No Call - INT CTL 1 and/or False Negative results on a small portion of the lot of test… Recall began April 16, 2025
• June 11, 2025Signature Laparoscopic Instruments… and 7 more productsClass IIInsulation on the tube did not extend fully to the proximal end of the shaft on the instrument, leaving an exposed (not insulated) area of the shaft… Recall began Jan. 9, 2024
• June 4, 2025Mauna Loa Dark Chocolate Covered Macadamias product is a snack product and packaged in 0.6oz and 4oz plastic…Class IUndeclared almond and cashew. Recall began April 25, 2025
• June 4, 2025a. Segmental Stem… and 5 more productsClass IIPotential for breach of Tyvek seals. Recall began Sept. 1, 2023
• June 4, 2025VITROS Chemistry Products CRP Slides…Class IIProduct was incorrectly assigned GEN 88 instead of GEN 83 on product carton, foil wrapper, and cartridge (cart) label. Recall began April 14, 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, 2025ABBOTT RAPID DX N AMERICA LLC MULTI ANALYTE LVL1&2250UL CHOLS CONTROL and 31 more productsClass IItransit delays of certain cold chain products due to severe thunderstorms which may caused the products to be stored outside the recommended labeled… Recall began April 24, 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
• June 4, 2025Apo B Reagent…Class IIIThe product Value Assignment Sheet (VAS) is used in calibration of the device. An erroneous value was included in the VAS which has the potential to… Recall began April 23, 2025
• May 28, 2025Zeke's Daddy's Granola…Class IProduct contains undeclared almond and cashew.
• May 28, 2025Organic traditions brand JUMBO PUMPKIN SEEDS…Class IProduct may be contaminated with Salmonella
• 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, 2025PRESIDENT BRAND…Class IIProduct contains undeclared sulfites (7.49mg/serving)
• 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, 2025Bonya Strawberry Yogurt Parfait… and 11 more productsClass IUndeclared Almonds Recall began March 29, 2025
• May 21, 2025MedicaLyte Liquid Bicarbonate Concentrate…Class IPotential for the presence of visible foreign matter. Recall began April 11, 2025
• May 14, 2025Trader Joe's Sesame Miso Salad with Salmon…Class Iundeclared milk
• 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 14, 2025Ambu aScope" 5 Broncho HD 5.6/2.8 Sampler Set…Class IIIncorrect labeling in which the front red pouch label did not match the actual size of the medical device. The label on the front of the scope… Recall began April 7, 2025
• May 7, 2025Outer carton labeled: "Cookie Butter Banana Pie" Inner carton labeled: "Tropical Key Lime Pie" Product…Class IIContains undeclared allergens (almonds).
• 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, 2025Brand Name: Quantum Informatics… and 1 more productClass IIMedical device software marketed without FDA clearance . Recall began March 19, 2025
• May 7, 2025HistoCore PELORIS 3…Class IIThere is a leakage issue associated with the tubing in the manifold of the instrument. Recall began April 2, 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, 2025Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasmaClass IISiemens Healthcare Diagnostics Inc., is recalling their Stratus CS Acute Care cTNI TestPak, an IVD test for cardiac troponin I in heparinized plasma… Recall began March 31, 2025
• April 30, 2025Apple Juice…Class IIPotential contamination with patulin. Recall began March 18, 2025
• April 30, 2025MO-CHA brand Premium Non-Dairy Creamer…Class IProduct does not declare the allergen, milk, on the label.
• April 30, 2025Walker's Wine Juice Pumpkin Juice 2.5…Class IMay be contaminated with Clostridium botulinum Recall began March 28, 2025
• April 30, 2025Zaarah Herbals brand Bhringraj Powder… and 3 more productsClass IProducts contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm; Recall began March 10, 2025
• April 30, 2025Brand Name: Rover Product Name: Mobile X-ray System Model/Catalog… and 1 more productClass IIPotential for internal fastening mechanism within generator of mobile x-Ray to fail.
• 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

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Showing the 600 most recent of 6,290 recalls.