The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

976–1000 of 27681

  • 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 (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 (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 (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
  • HighFDA (Devices)·Z-2010-2026·2026-05-06

    Medline Neuro Sponges in Medical Procedure Kits Recalled for High Endotoxin

    Medline Industries is recalling Medline medical procedure kits containing Neuro Sponges (EH BRONCHOSCOPY, Kit Number DYNJT3270) 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: EH BRONCHOSCOPY, Medline Kit Number/SKU DYNJT3270
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1991-2026·2026-05-06

    Depuy Synthes ATTUNE Revision Hinge Femoral Knee Component Recall

    Depuy Synthes is recalling 3 units of the ATTUNE Revision Hinge Femoral (Right, Size 5, Cemented) knee implant due to external sterile packaging adhered to internal sterile packaging, potentially compromising product sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 5 CEM. Part Number: 150450205.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1987-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling one lot of ATTUNE Revision Hinge Femoral components (left size 7, part number 150450107) due to external sterile packaging adhered to internal packaging, potentially compromising product sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL LT SZ 7 CEM. Part Number: 150450107.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2019-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled for Endotoxin

    Medline is recalling medical procedure kits containing Medline Neuro Sponges due to higher-than-expected endotoxin levels found during an internal review, indicating in-market product may be out-of-specification.

    Product
    Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows: 1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D; 2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920F; 3. MEM MAXILLOFACIAL PACK-LF, Medline Kit Number/SKU DYNJ0660040S; 4.…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2013-2026·2026-05-06

    Medline Medical Procedure Kits with Neuro Sponges Recalled

    Medline Industries 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, labeled as follows: 1. NEURO PACK, Medline kit number/SKU DYNJ64479; 2. CRANIO/NEURO/SPINE, Medline kit number/SKU DYNJ901072D.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2045-2026·2026-05-06

    Medline medical convenience kits recalled for non-sterile alcohol prep pads

    Medline Industries is recalling multiple medical convenience kits nationwide due to Webcol Large Alcohol Prep Pads that were found to be non-sterile. A contaminant (Paenibacillus phoenicis) was discovered during a routine sterilization dose audit.

    Product
    Medline and Centurion medical convenience kits, containing Webcol Large Alcohol Prep Pads, labeled as: 1. LVAD DRIVELINE KIT (Centurion), Medline Kit SKU DT17360 (Centurion); 2. LONG TERM/INPATIENT IV SECUREMENT SET (Centurion), Medline Kit SKU IVS1975A; 3. CVC DRESSING…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1990-2026·2026-05-06

    DePuy Synthes ATTUNE Revision Hinge Femoral Component Sterility Recall

    DePuy Synthes is recalling 3 units of the ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM due to external sterile packaging found adhered to internal packaging, potentially compromising sterility.

    Product
    Depuy Synthes, ATTUNE REVISION HINGE FEMORAL RT SZ 4 CEM. Part Number: 150450204.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1943-2026·2026-05-06

    Mesh Style Tip Protectors recalled lacking FDA clearance

    Healthmark Industries Co., Inc. is recalling Mesh Style Tip Protectors (models CSW-03-2.0 and CSW-04-4.0) distributed nationwide because the product does not have FDA clearance.

    Product
    Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
    Category
    Medical Device
    Distribution
    Distributed nationwide