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 deaths or serious injuries are reported, 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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5776–5800 of 13666

  • HighFDA (Devices)·Z-2493-2024·2024-08-14

    Medication dispensing cabinet software issue causes incorrect medication bin labels

    A software issue in BD PYXIS MEDBANK automated medication dispensing cabinets can cause incorrect medication bin labels on restock labels, potentially leading to medication storage errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-2HH-6FH, REF: 169-88 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2477-2024·2024-08-14

    GE Brivo MR355 MRI System Software Issue Causing Implant Overheating Risk

    GE HealthCare has recalled certain Brivo MR355 MRI systems due to a software issue that can cause overheating of implanted medical devices in specific imaging scenarios. Approximately 375 units have been affected worldwide.

    Product
    Brivo MR355, with affected software versions: SV20.3, SV23.3, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2532-2024·2024-08-14

    FDA Recalls CryoPatch Cardiac Tissue Grafts Due to Invalid Test Results

    Artivion has recalled CryoPatch SG cardiac tissue patches used in pulmonary surgeries due to approval and release with invalid test results. Patients who received implants should consult their healthcare provider.

    Product
    (1) CryoPatch SG Pulmonary Human Cardiac Hemi-Artery - Artery Patch, SGPH00 Cryopreserved Decellularized Cardiac Tissue Allograft Prepared with SynerGraft (SG) Technology; and (2) CryoPatch SG Pulmonary Human Cardiac Branch Patch, SGP020, Cryopreserved Decellularized Cardiac Tis
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2502-2024·2024-08-14

    Automated Dispensing Cabinet Software Issue Causing Incorrect Medication Bin Labels

    A software defect in the BD PYXIS MEDBANK automated dispensing cabinet causes incorrect medication bin locations to be printed on restock labels, potentially resulting in medication dispensing errors. No illnesses or injuries have been reported.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-3FH-P, REF: 169-98 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2486-2024·2024-08-14

    Automated dispensing cabinet software issue causes incorrect medication bin labels

    CareFusion is recalling 232 automated medication dispensing cabinets due to a software issue that may print incorrect medication bin labels, potentially causing medication dispensing errors.

    Product
    BD PYXIS MEDBANK MINI CR-4HH-P, REF: 169-115 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2468-2024·2024-08-14

    GE MR450w 1.5T MRI software defect may cause implant overheating

    GE MR450w 1.5T MRI systems may overheat MR-conditional implants when using specific imaging sequences with Low SAR Mode. No injuries reported; 1,607 units affected worldwide.

    Product
    Optima MR450w 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2470-2024·2024-08-14

    GE SIGNA Voyager MRI systems risk implant overheating under specific configurations

    GE SIGNA Voyager MRI systems may exceed prescribed radiofrequency limits under specific operating conditions, risking overheating of MR conditional implants. The issue occurs with certain imaging sequences when the Optimized T2 FLAIR option is disabled.

    Product
    SIGNA Voyager, with affected software versions: PX26.0 to PX26.6, VX28.0, VX29.1, VX29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2480-2024·2024-08-14

    MRI System Software Issue Can Overheat Implanted Medical Devices

    GE HealthCare recalled 23 SIGNA Victor MRI systems due to a software issue that can cause MR conditional implants to overheat. The defect occurs under specific imaging mode and configuration combinations.

    Product
    SIGNA Victor, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2461-2024·2024-08-14

    MRI System Software Miscalculation May Overheat Patient Implants

    A software error in GE SIGNA Hero MRI systems can cause overheating of MR conditional implants under specific conditions. The recall affects 95 units distributed worldwide.

    Product
    SIGNA Hero, with affected software versions: PX29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2490-2024·2024-08-14

    BD PYXIS automated medication cabinet software defect causes incorrect bin labels

    A software defect in BD PYXIS MEDBANK automated medication dispensing cabinets may cause the incorrect medication bin to be printed on restock labels, potentially resulting in medication errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-12HH-1FH, REF: 169-84 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2515-2024·2024-08-14

    Centurion Procedure Kits with Defective Syringes Recalled Worldwide

    Medline Industries is recalling Centurion procedure kits due to defective plastic syringes affected by an FDA safety alert. The syringes may leak or break and pose a potential risk to patient health.

    Product
    Centurion procedure kits labeled as NEURO ANGIO PACK, Pack Number DYNDA1431A
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2516-2024·2024-08-14

    Medline Centurion Procedure Kits Recalled for Syringe Leaks, Breakage, and Quality Defects

    Medline has recalled Centurion procedure kits containing syringes affected by an FDA safety alert. The syringes may leak, break, or have other quality defects, posing a risk to patient health.

    Product
    Centurion procedure kits labeled as: 1) CVC INSERT BUNDLE 16CM, Pack Number ECVC3260; 2) CVC DOUBLE LUMEN 16CM, Pack Number ECVC8105
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2465-2024·2024-08-14

    GE Discovery MR750w MRI System Software May Overheat Implants

    GE HealthCare is recalling certain Discovery MR750w 3.0T MRI systems where the magnetic field strength (B1+RMS) can exceed the prescribed limit during specific imaging sequences, potentially causing overheating of MR-conditional implants.

    Product
    Discovery MR750w 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.5, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2517-2024·2024-08-14

    American Contract Systems Hand Pack Convenience Kit Sterilization Failure

    American Contract Systems is recalling Hand Pack convenience kits that may not be sterile due to insufficient aeration time during sterilization. Affected devices distributed in CA, KS, ME, MN, MO, NE, and SD may pose a safety risk.

    Product
    American Contract Systems Hand Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2488-2024·2024-08-14

    BD PYXIS Automated Medication Cabinet Software Label Error Affects 11 Units

    CareFusion's BD PYXIS medication dispensing cabinet with software version 3.9.1.9 may print incorrect bin labels during restocking, potentially leading to wrong medication dispensing. Eleven units distributed nationwide are affected.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FH-P, REF: 169-82 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2466-2024·2024-08-14

    SIGNA PET/MR diagnostic imaging system poses implant overheating risk

    GE HealthCare recalled SIGNA PET/MR systems with specific software versions due to a configuration issue that can cause RF energy to exceed safety limits, potentially overheating MR-conditional implants.

    Product
    SIGNA PET/MR, with affected software versions: MP24.0, MP26.0, MP26.1, MR30.0, MR30.1; Tomographic imager combining emission computed tomography with nuclear magnetic resonance
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2487-2024·2024-08-14

    BD PYXIS medication cabinet software error causes incorrect bin labels

    A software issue in the BD PYXIS MDBNK medication dispensing cabinet may cause restock labels to print with incorrect bin locations, potentially affecting medication storage accuracy.

    Product
    BD PYXIS MDBNK TWR MN CR-4HH-5FM-P RxNow, REF: 169-131 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2513-2024·2024-08-14

    Surgical Staple Reinforcement Devices Recalled for Incorrect Expiration Dating

    W.L. Gore & Associates recalled 51 units of GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement due to incorrect expiration date labeling. The devices were labeled with a four-year and ten-day expiration date instead of the validated two-year shelf life.

    Product
    GORE SEAMGUARD Bioabsorbable Staple Line Reinforcement Configured for Circular Staplers, 25mm; Catalog number: 1BSGC25;
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2507-2024·2024-08-14

    Integra Recalls TruDi NAV Suction Instruments for Calibration Error

    Integra LifeSciences has recalled 265 TruDi NAV Suction Instruments due to incorrect calibration. The miscalibrated units may display inaccurate position information during surgical navigation procedures.

    Product
    TruDi NAV Suction, 0 Degrees; Model/Catalog Number: TDNS000Z. TruDi" NAV Suction Instruments are intended for use with the TruDi" Navigation System during surgical procedures in ENT medicine and skull base surgery
    Category
    Medical Device
    Distribution
    35 states
  • HighFDA (Devices)·Z-2464-2024·2024-08-14

    GE Discovery MR750 MRI System Software May Cause Implant Overheating

    GE HealthCare is recalling certain MR750 MRI systems with specific software versions. When using particular imaging sequences in Low SAR Mode without the Optimized T2 FLAIR option, the radiofrequency field can exceed safe limits, risking overheating of MR-conditional implants.

    Product
    Discovery MR750 3.0T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0 to DV26.4, DV29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2467-2024·2024-08-14

    Discovery MR450 MRI System Can Overheat Implants Under Specific Conditions

    GE Discovery MR450 MRI systems with certain software versions can cause implant overheating under specific scanning conditions. 23 units worldwide require firmware updates.

    Product
    Discovery MR450 1.5T, with affected software versions: DV24.0, DV25.0, DV25.1, DV26.0; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2459-2024·2024-08-14

    SIGNA Architect MRI System Software Can Exceed Implant Heating Limits

    GE Medical Systems is recalling SIGNA Architect MRI systems in which software may allow B1+ radiofrequency exposure to exceed user-prescribed limits during certain T2 FLAIR imaging sequences, risking MR-conditional implant overheating.

    Product
    SIGNA Architect, with affected software versions: DV26.0 to DV26.3, DV27.0 to DV27.3, DV28.0 to DV28.5, DV29.0, DV29.1, DV29.2, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2485-2024·2024-08-14

    Automated medication cabinet software prints incorrect bin labels

    The BD PYXIS MEDBANK MINI automated dispensing cabinet software may print incorrect bin locations on restock labels, potentially causing medications to be placed in wrong locations.

    Product
    BD PYXIS MEDBANK MINI CR-2HH-1FH-P, REF: 169-114 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2525-2024·2024-08-14

    Siemens x-ray display system support arm may lower unexpectedly

    Siemens Luminos Agile Max x-ray imaging systems have a support arm that may unintentionally lower during display positioning, creating an injury risk.

    Product
    Luminos Agile Max -Intended to visualize anatomical structures by converting an x-ray pattern into a visible image. Model Number: 10762472
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2471-2024·2024-08-14

    GE SIGNA 1.5T MR Systems May Overheat Implants in Low SAR Mode

    GE Medical Systems recalled 2,146 SIGNA 1.5T MR systems that may overheat implants during certain imaging sequences in Low SAR mode due to a software defect in radiofrequency safety calculations.

    Product
    1.5T SIGNA HDxt Family, with affected software versions: HD16.0_V03 to HD16.4, HD23.0_V03, HD28.0, HD29.1, MR30.0, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states