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.

10476–10500 of 22146

  • HighFDA (Devices)·Z-2499-2024·2024-08-14

    Automated Medication Dispenser Software Bug Causes Incorrect Bin Labels

    BD PYXIS MEDBANK automated medication dispensers may print incorrect medication bin labels due to a software defect, risking medication handling errors in healthcare settings.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-4FM-P, REF: 169-94 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1641-2024·2024-08-14

    Black Forge Kitchen Knives Recalled for Elevated Lead Levels

    Black Forge Knives is recalling multiple kitchen knife models distributed in Georgia and via Bespoke Post due to elevated lead levels in the blades.

    Product
    1- Name: Carbon Steel Utility Kitchen Knife Model: CSK1700 Size: Total length: 10.25" Type of packaging: Each knife packed in a single box 2- Name: Carbon Steel Utility Kitchen Cleaver Knife Model: CSK1701 Size: Total length: 10.5" Type of pac
    Category
    Consumer Product
    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
  • 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-2521-2024·2024-08-14

    Surgical Convenience Kits Recalled for Potential Sterilization Failure

    American Contract Systems is recalling three surgical convenience kits due to potential sterilization failure from insufficient aeration time during processing.

    Product
    American Contract Systems Extremity convenience kit, American Contract Systems Hand Pack convenience kit, and American Contract Systems Total Knee Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-2520-2024·2024-08-14

    Medical Procedure Kit Recalled Over Potential Sterilization Compromise

    American Contract Systems is recalling Special Procedure Pack convenience kits due to insufficient aeration time during sterilization, which may have compromised sterility. Distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Special Procedure Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2524-2024·2024-08-14

    American Contract Systems Spine Pack kits recalled for insufficient sterilization aeration

    American Contract Systems is recalling Spine Pack convenience kits (Lot 980241) due to incomplete post-sterilization aeration. The affected kits were distributed in California, Kansas, Maine, Minnesota, Missouri, Nebraska, and South Dakota.

    Product
    American Contract Systems Spine Pack convenience kit
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-1723-2024·2024-08-14

    Panaderia Guatemex Curenitos Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling 170 bags of Curenitos due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Curenitos packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2472-2024·2024-08-14

    GE SIGNA Creator MRI systems software defect risks patient implant overheating

    GE HealthCare recalled certain SIGNA Creator MRI systems due to a software defect where the predicted magnetic field strength can exceed prescribed limits in Low SAR Mode with specific imaging sequences, potentially causing overheating of MR-conditional implants.

    Product
    SIGNA Creator, 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 (Food)·F-1650-2024·2024-08-14

    Premo Turkey & Swiss 6oz Deli Meat Recalled for Potential Salmonella

    Lipari Foods is recalling Premo Turkey & Swiss 6oz deli meat packages due to potential Salmonella contamination. No illnesses have been reported.

    Product
    Premo Turkey & Swiss 6oz, clear plastic, UPC 612510001042, 4 retail packages per wholesale case
    Category
    Food
    Distribution
    16 states
  • HighFDA (Devices)·Z-2495-2024·2024-08-14

    BD PYXIS Medication Cabinet Software Defect Causes Incorrect Restock Labels

    A software issue in BD PYXIS automated medication dispensing cabinets can cause restock labels to print with incorrect bin numbers. Four units are affected nationwide.

    Product
    BD PYXIS MEDBANK TWR MN CR-4HH-1FH-4FM-P, REF: 169-90 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0630-2024·2024-08-14

    Estradiol Cypionate Injection Recalled Due to Lack of Sterility Assurance

    Empower Pharmacy is recalling Estradiol Cypionate Injection due to lack of assurance of sterility. The recall affects 2,797 units distributed nationwide within the United States.

    Product
    Empower Pharmacy, Estradiol Cypionate Injection, 10mg/mL, 5mL Sterile Multiple Dose Vial, For IM or SQ use only, RX only, Compounded by: Empower Pharmacy 7601 N Sam Houston Pkwy W Ste 100, Houston, TX 77064
    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-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-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 (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 (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 (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 (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 (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