The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

2776–2800 of 88106

  • ModerateFDA (Devices)·Z-2130-2026·2026-05-13

    Medline Surgical Packs recalled due to sterilization equipment calibration issues

    Medline Industries is recalling certain surgical packs because calibration issues with sterilization and packaging equipment may have affected sterility assurance. All recalled units were exposed to validated sterilization cycles but the calibration problems could impact sterility integrity.

    Product
    Medline Surgical Packs: 1) PACK,UNIVERSAL,ULTRAGARD,5/CS, Model Number: DYNJP1050UG; 2) PACK,SHOULDER,DRAPE,POUCH,10/CS, Model Number: DYNJP8401
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0511-2026·2026-05-13

    Buspirone Hydrochloride Tablets 5 mg Recalled for Subpotency

    Unichem Pharmaceuticals USA Inc. is recalling Buspirone Hydrochloride Tablets, USP, 5 mg because the drug is subpotent. The recall affects approximately 10,875 bottles distributed nationwide.

    Product
    BUSPIRONE HYDROCHLORIDE — BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0492-2026·2026-05-06

    GenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling GenTeal Tears Lubricant Eye Gel nationwide due to FDA inspection observations indicating the product may lack assurance of sterility. Consumers should not use affected lots.

    Product
    GENTEAL TEARS — GENTEAL TEARS (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-2016-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline is recalling multiple medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels that may render the product out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. OPEN HEART CDS PART A, Medline Kit Number/SKU CDS840402AI; 2. OPEN HEART CDS, Medline Kit Number/SKU CDS984890V; 3. RR-NEURO VASCULAR PACK-LF, Medline Kit Number/SKU DYNJ0394874L…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Drugs)·D-0491-2026·2026-05-06

    Systane Lubricant Eye Gel Recalled Due to Sterility Concerns

    Alcon Research LLC is recalling Systane Lubricant Eye Gel Night Gel (10g) distributed nationwide due to FDA inspection observations regarding lack of assurance of sterility that may impact product quality.

    Product
    SYSTANE — SYSTANE (HYPROMELLOSE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1770-2026·2026-05-06

    Boston Scientific Pacemakers Subject to Software Update Advisory

    Boston Scientific is issuing a software update (Brady SMR6) for certain ACCOLADE and PROPONENT pacemakers and cardiac resynchronization therapy devices. The advisory population is expanding to include all dual-chamber extended life and CRT-P devices.

    Product
    Boston Scientific Pacemaker, Implantable Pulse Generator, Pacemaker (non- Cardiac Re-Synchronization Therapy) labeled as: 1. ESSENTIO SR SL, Model Number L100; 2. ESSENTIO DR SL Pacemaker, Model Number L101; 3. ESSENTIO SR SL MRI Pacemaker, Model Number L110; 4.…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1771-2026·2026-05-06

    Boston Scientific Cardiac Pacemakers Require Software Update

    Boston Scientific is expanding a software advisory for ACCOLADE family pacemakers and cardiac resynchronization therapy devices. Updated software (Brady SMR6) is now available to address identified issues.

    Product
    Boston Scientific Cardiac Resynchronization Therapy (CRT)labeled as: 1. VALITUDE CRT-P EL, Model Number U125; 2. VALITUDE CRT-P EL MRI, Model Number U128; 3. VISIONIST CRT-P EL, Model Number U225; 4. VISIONIST CRT-P EL, Model Number U226; 5. VISIONIST CRT-P EL MRI…
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1947-2026·2026-05-06

    AIDBAG First Aid Kits with Recalled Blood Glucose Meters Recalled

    North American Rescue LLC. is recalling AIDBAG first aid kits containing McKesson TRUE Metrix PRO blood glucose meters that display an E-5 error code incorrectly, potentially delaying appropriate patient treatment.

    Product
    AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for the appropriate level provider to evaluate and treat patients at the point-of-injury / point-of-illness. The original manufacturer labeling…
    Category
    Medical Device
    Distribution
    2 states
  • SevereFDA (Devices)·Z-1984-2026·2026-05-06

    Immy Myco DDR Trident Neutralization Buffer B Recalled for Potential Contamination

    Immuno-Mycologics, Inc. is recalling Immy Myco DDR Trident Bulk Neutralization Buffer B (60 X 30 mL, Lot F5061154) because the product may contain contaminants. The buffer is used for clinical specimen processing for Mycobacterium spp. diagnosis.

    Product
    Immy, Myco DDR Trident, Bulk Neutralization Buffer B (60 X 30 mL), REF: TBPN67-60 For processing of clinical specimens for Mycobacterium spp. diagnosis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Food)·H-0686-2026·2026-05-06

    Enoki mushrooms recalled after testing positive for Listeria monocytogenes

    Enoki mushrooms distributed by Hemu Trading are being recalled after the product tested positive for Listeria monocytogenes. 1,056 cases are affected.

    Product
    Black label with blue lettering. FOOD Korean Food, ENOKI MUSHROOM, 150g clear plastic package; Product of Korea, Keep Refrigerated. Distributed by Hemu Trading Inc. UPC: 8801234567893
    Category
    Food
    Distribution
    3 states
  • SevereFDA (Devices)·Z-2021-2026·2026-05-06

    Medline and Centurion Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline Industries is recalling Medline and Centurion medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may cause the products to be out-of-specification.

    Product
    Medline and Centurion medical procedure kits, containing Medline Neuro Sponges (1229 in total), HEAD & NECK TRAY, SINUS, SMR, etc.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-1827-2026·2026-05-06

    WHILL Model F Powered Wheelchair Bluetooth Communication Vulnerability

    WHILL, INC. is recalling WHILL Model F powered wheelchairs with software versions before HMI 2.23 and MC 1.05 due to a Bluetooth Low Energy (BLE) communication vulnerability identified through the CISA Vulnerability Disclosure Program.

    Product
    WHILL Model F, with software versions before HMI: 2.23 / MC: 1.05; the device is an indoor/outdoor, foldable battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    1 state
  • SevereFDA (Drugs)·D-0499-2026·2026-05-06

    Optase Dry Eye Drops Recalled for Lack of Sterility Assurance

    Scope Health is recalling Optase Dry Eye Intense Drops (Glycerin 0.2%) due to lack of assurance of sterility. The product is distributed nationwide.

    Product
    OPTASE — OPTASE (GLYCERIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1996-2026·2026-05-06

    iLet Bionic Pancreas Software Versions Recalled for Delayed CGM Readings

    Beta Bionics is recalling iLet Bionic Pancreas units with software versions 1.4.2 and 1.4.3 due to a compatibility issue with Dexcom G7 sensors that can cause delayed glucose readings and loss of automatic insulin adjustments.

    Product
    iLet Bionic Pancreas, REF: BB1001
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1826-2026·2026-05-06

    WHILL Model C2 Powered Wheelchair Recalled for Bluetooth Security Vulnerability

    WHILL Model C2 powered wheelchairs with software versions before HMI 2.22 and MC 1.13 are recalled due to a Bluetooth Low Energy (BLE) communication vulnerability identified by CISA. Approximately 4,685 units distributed in Kansas are affected.

    Product
    WHILL Model C2, with software versions before HMI: 2.22 / MC: 1.13; device is an indoor/outdoor battery-operated 2-wheel drive (rear-wheel drive) powered wheelchair.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1989-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Recall

    DePuy Synthes is recalling 3 units of ATTUNE Revision Hinge Femoral RT Size 3 Cement components due to external sterile packaging that was adhered to internal sterile packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 3 CEM. Part Number: 150450203.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2020-2026·2026-05-06

    Medline Medical Procedure Kits With Neuro Sponges Recalled

    Medline Industries is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels that may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. ZALE STEREOTACTIC CDS, Medline Kit Number/SKU CDS983173G; 2. EPISTAXIS TRAY, Medline Kit Number/SKU DYNDA3240; 3. RHINO PACK, Medline Kit Number/SKU DYNJ46504B; 4. MSC SEPTO RHINO…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2027-2026·2026-05-06

    Medline Medical Procedure Kits Recalled for High Endotoxin Levels

    Medline is recalling medical procedure kits containing neuro sponges due to higher-than-expected endotoxin levels that may be out-of-specification. The kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (1050 in total), BIOBURDEN TEST KIT, NEURO, ROBOTIC, ACDF, ENT, etc.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2000-2026·2026-05-06

    i-STAT Blood Gas Analyzer Cartridges Recalled for Inaccurate Results

    Abbott is recalling certain i-STAT EG6+, EG7+, and G3+ blood gas cartridges that may report falsely high CO2 and falsely low pH results due to a manufacturing issue, potentially leading to unnecessary or harmful clinical interventions.

    Product
    i-STAT EG6+ cartridge; List Number: 03P77-25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·H-0684-2026·2026-05-06

    My Mochi strawberry frozen dessert contains a foreign object

    My Mochi Strawberry flavoured Non-Dairy Frozen Dessert is being recalled after a foreign object was found inside a retail container. 1,270 cases are affected.

    Product
    My Mochi Strawberry flavored Non-Dairy Frozen Dessert; 7.5 oz; 6 pieces per container. UPC# 0-70934-99645-8
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2044-2026·2026-05-06

    Medline Centurion Medical Kits Recalled for Non-Sterile Alcohol Prep Pads

    Medline Industries is recalling Centurion medical convenience kits containing Webcol Large Alcohol Prep Pads after Cardinal Health determined the pads are non-sterile due to bacterial contamination discovered during sterilization testing.

    Product
    Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: DERMATOLOGY SHAVE KIT, Medline Kit SKU SK395
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2031-2026·2026-05-06

    Insulin Pump Batteries Recalled After Sudden-Shutdown Reports

    OmniDose is recalling 23,000 lithium battery packs used in its X4 insulin pumps after reports of unexpected shutdown.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: GENERAL KIT, Medline Kit Number/SKU DYNJ905664I
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2028-2026·2026-05-06

    Centurion Surgical ENT Prep Kits with Medline Neuro Sponges Recalled

    Medline Industries is recalling Centurion Surgical ENT Prep Kits (Medline Neuro Sponges) due to higher-than-expected endotoxin levels that may render the product out-of-specification. Approximately 3,000 kits have been distributed worldwide.

    Product
    Centurion medical procedure kits, containing Medline Neuro Sponges, labeled as follows: SURGICAL ENT PREP KIT, Medline Kit Number/SKU MNS11715
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2033-2026·2026-05-06

    Medline medical procedure kits recalled for elevated endotoxin levels

    Medline Industries is recalling medical procedure kits containing Neuro Sponges due to higher-than-expected endotoxin levels found on the products. Affected kits were distributed worldwide.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges (961 in total), NEURO,
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2006-2026·2026-05-06

    Leksell Vantage Arc System locking mechanism may not secure properly

    Elekta, Inc. is recalling the Leksell Vantage Arc System because locking mechanisms may fail to properly secure to the Arc system, which could cause coordinate shifting during medical procedures.

    Product
    Brand Name: Leksell Vantage Arc System REF: 1053958
    Category
    Medical Device
    Distribution
    32 states