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.

10451–10475 of 22146

  • HighFDA (Food)·F-1725-2024·2024-08-14

    Concha Mexicana Pastries Recalled Due to Undeclared Soy Allergen

    Panaderia Guatemex is recalling Concha Mexicana pastries due to undeclared soy allergen. Consumers with soy allergies should not consume this product.

    Product
    Panaderia Guatemex - Concha Mexicana packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2512-2024·2024-08-14

    Baxter Precision Surgical Table Recall: Loose Spring Pins Risk

    Baxter Healthcare Corporation is recalling the PST 500 U Precision Surgical Table due to loose spring pins that can cause the tabletop to unexpectedly tilt or move, potentially causing unintended patient movement during surgery.

    Product
    Baxter PST 500 U, Precision Surgical Table, Part number (product code) 4080300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2479-2024·2024-08-14

    GE SIGNA Prime MR system can exceed RF safety limits in Low SAR mode

    GE Medical Systems is recalling 72 SIGNA Prime MR imaging systems worldwide. Under specific imaging conditions, the systems can exceed prescribed radiofrequency safety limits, potentially causing MR conditional implants to overheat.

    Product
    SIGNA Prime, with affected software versions: MR30.1; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-2529-2024·2024-08-14

    Paraffin Embedding Station Recalled for Internal Fire and Toxic Smoke Risk

    The FDA is recalling 180 Leica HistoCore Arcadia H paraffin embedding stations due to a sealing defect in the paraffin tank that can cause toxic smoke and internal fire.

    Product
    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.
    Category
    Medical Device
    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-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 (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 (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-1643-2024·2024-08-14

    Izzio Everything Rolls recalled for potential plastic contamination

    Izzio Artisan Bakery is recalling Izzio Everything Rolls due to potential plastic contamination. Affected lot numbers are 24183C and 24183A.

    Product
    Izzio Everything Roll packaged in 12oz plastic bag, 6 rolls per bag - 16 bags per case.
    Category
    Food
    Distribution
    7 states
  • 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 (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-1649-2024·2024-08-14

    Premo Meat Lovers Recall Due to Potential Salmonella Contamination

    Premo Meat Lovers 7oz packages are being recalled due to potential Salmonella contamination. Affected products have a Best By Date of 7/13/24 and Lot Code 25202406.

    Product
    Premo Meat Lovers 7oz, clear plastic, UPC 612510093832, 4 retail packages per wholesale case
    Category
    Food
    Distribution
    16 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-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 (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-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-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-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-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-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-1726-2024·2024-08-14

    Panaderia Guatemex Casco bread recalled for undeclared soy allergen

    Panaderia Guatemex is recalling Casco bread due to undeclared soy allergen. The product was distributed in Georgia, Kentucky, and Tennessee.

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