The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

7776–7800 of 52968

  • HighFDA (Devices)·Z-2475-2024·2024-08-14

    GE SIGNA MR355 MRI System Recalled for Potential Implant Overheating Risk

    GE SIGNA MR355 MRI systems running software versions SV25.5 or SV25.6 may cause implant overheating in certain scanning conditions. Risk occurs when using specific imaging sequences with the Optimized T2 FLAIR feature disabled.

    Product
    SIGNA MR355, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Drugs)·D-0634-2024·2024-08-14

    Gabapentin 600 mg Tablets Recalled Due to Metformin Contamination

    Granules Pharmaceuticals Inc. is recalling Gabapentin Tablets 600 mg nationwide after fused Metformin ER tablets were found in bottles, creating a risk of unintended medication exposure.

    Product
    GABAPENTIN — GABAPENTIN (GABAPENTIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1717-2024·2024-08-14

    Panaderia Guatemex Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex Liso bread may contain undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Liso packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • 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-2498-2024·2024-08-14

    Automated Dispensing Cabinet Software Error May Print Incorrect Medication Bin Labels

    CareFusion's BD PYXIS MEDBANK automated dispensing cabinet contains a software flaw that may print incorrect medication bin labels, potentially leading to dispensing of wrong medications.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-2FH-2FM-P, REF: 169-93 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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
  • HighFDA (Devices)·Z-2501-2024·2024-08-14

    Medication Dispensing Cabinet Software Error Can Print Incorrect Bin Labels

    A software error in CareFusion's BD PYXIS automated medication dispensing cabinet can cause incorrect medication bin numbers to be printed on restock labels, risking medication dispensing errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-8HH-2FH-1FM-P, REF: 169-97 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2538-2024·2024-08-14

    Steris Endoscope Reprocessor Hookups: Incorrect Instructions Risk Improper Disinfection

    Steris recalls Hookup Model 2-8-540CAS endoscope reprocessor units due to incorrect instructions that could prevent proper disinfection. Using incorrect hookup connections may lead to patient contamination or infection risk.

    Product
    Hookup Model/Catalog Number: 2-8-540CAS Product Description: Hookups provide the interface between an Advantage Plus" Automated Endoscope Reprocessor and Advantage Plus" Pass-Thru Automated Endoscope Reprocessor ( AER ) and endoscopes, which allow perfusion of liquids dispens
    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-2474-2024·2024-08-14

    SIGNA MR380 MRI system software may exceed implant heating limits

    GE SIGNA MR380 MRI systems with software versions SV25.5 or SV25.6 may exceed radiofrequency heating limits during certain imaging sequences, potentially causing MR-conditional implants to overheat. The issue occurs in Low SAR Mode when specific T2 FLAIR sequences are used with the Optimized T2 FLAIR option disabled.

    Product
    SIGNA MR380, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • 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 (Food)·F-1718-2024·2024-08-14

    Panaderia Guatemex Besos Bakery Products Recalled for Undeclared Soy

    Panaderia Guatemex is recalling 170 bags of Besos packaged bakery products distributed in Georgia, Kentucky, and Tennessee because they contain undeclared soy, a known allergen that poses a risk to consumers with soy allergies.

    Product
    Panaderia Guatemex - Besos packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-1657-2024·2024-08-14

    Palmer Patriotic Snack Mix Recalled for Potential Salmonella Contamination

    Palmer & Company is recalling Palmer Patriotic Snack Mix (13 oz, Best By 1/19/25–2/1/25) due to potential Salmonella contamination. The product was distributed nationwide in the United States and Canada.

    Product
    Palmer Patriotic Snack Mix, A Seasonal Mix of Sweet & Salty Favorites, Net Wt. 13 oz., UPC 77232 37061, 12/13oz case
    Category
    Food
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2496-2024·2024-08-14

    Automated Medication Dispensing Cabinet Software Issue with Incorrect Bin Labeling

    BD PYXIS MEDBANK automated medication dispensing cabinets with software version 3.9.1.9 may generate incorrect bin location labels during restocking. This could cause medications to be placed in wrong storage locations.

    Product
    BD PYXIS MEDBANK TWR MN CR-4HH-5FM-P, REF: 169-91 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2483-2024·2024-08-14

    MRI System Software Error Can Overheat Patient Implants

    GE Medical Systems recalled three SIGNA 7.0T MRI systems due to a software error that can exceed preset safety limits during imaging, potentially overheating implants in patients under certain conditions.

    Product
    SIGNA 7.0T, with affected software versions: 7T29.1, MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • 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
  • HighNHTSA·24V610000·2024-08-14

    Holiday Rambler Admiral motorhomes recalled for missing GFCI outlet protection

    Certain 2019-2025 Holiday Rambler Admiral and other RVs have exterior patio outlets lacking GFCI protection when powered by generator or shore cord, increasing electrical shock risk. Dealers will install GFCI devices free of charge.

    Product
    FLEETWOOD — FLEETWOOD, HOLIDAY RAMBLER FLAIR, ADMIRAL, ECLIPSE, FLEX
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2492-2024·2024-08-14

    Automated Medication Cabinet Software Bug May Print Wrong Bin Labels

    CareFusion's BD PYXIS MEDBANK medication dispensing cabinets (software 3.9.1.9) have a software defect that may cause restock labels to print incorrect medication bin locations, creating a risk of medication dispensing errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-14HH-P, REF: 169-86 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2489-2024·2024-08-14

    BD PYXIS MEDBANK Automated Cabinet May Print Incorrect Medication Bin Labels

    A software issue in the BD PYXIS MEDBANK automated medication dispensing cabinet can cause incorrect bin labels to be printed for restock operations. This could lead to medication administration errors affecting patient safety.

    Product
    BD PYXIS MEDBANK TWR MN CR-10HH-2FM-P, REF: 169-83 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1642-2024·2024-08-14

    Izzio Everything Sourdough Recalled for Potential Plastic Contamination

    Izzio Artisan Bakery is recalling Izzio Everything Sourdough bread due to potential plastic foreign material. The 24oz loaves with specific lot numbers were distributed to retailers and distribution centers in seven states.

    Product
    Izzio Everything Sourdough. Single 24oz loaf packaged into plastic bag. 12 loaves per case.
    Category
    Food
    Distribution
    7 states
  • HighFDA (Food)·F-1640-2024·2024-08-14

    Lunds & Byerlys Caesar Salad Recalled for Undeclared Shellfish and Allergens

    Lunds & Byerlys is recalling Grilled Chicken Caesar Salad that is mislabeled; it is actually Korean Shrimp Salad containing undeclared shellfish, tree nuts (cashew), soybeans, and sesame. Distributed in Minnesota, Lot 301335, Use By 12/04/23.

    Product
    Lunds & Byerlys grilled chicken caesar salad, Net Wt: 9.0 oz. (255.2g) UPC 0 18169-66428 5. Lunds & Byerlys, Edina, MN 55424
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1724-2024·2024-08-14

    Panaderia Guatemex Gusano Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Gusano bread because it contains undeclared soy. People with soy allergies should not consume this product and should return it to the store.

    Product
    Panaderia Guatemex - Gusano packaged in plastic bag
    Category
    Food
    Distribution
    3 states