The Recall Desk

Agency

U.S. Food and Drug Administration

The FDA regulates food, drugs, biologics, medical devices, and tobacco. We aggregate Class I, II, and III enforcement actions across its three recall streams.

Visit the official FDA site →

About FDA recalls

The FDA is the single biggest source of US product recalls by volume. Its enforcement workload splits into three streams — Foods (everything from infant formula to leafy greens to nutritional supplements), Drugs (prescription medicines, over-the-counter products, and active pharmaceutical ingredients), and Medical Devices (everything from implants to home blood-pressure monitors). The Recall Desk ingests all three from the openFDA enforcement endpoint every six hours.

FDA classifies every recall as Class I, II, or III. Class I means there is a reasonable probability that using the product will cause serious health consequences or death — these are the recalls you should treat as urgent. Class II means the product may cause temporary or medically reversible harm. Class III means the product is unlikely to cause adverse health consequences but still violates FDA rules. We map these classifications into our 1–5 severity score using the rubric on the methodology page.

Medical-device recalls are the highest-volume stream by far — software-update letters, calibration corrections, and IFU updates all show up in enforcement reports alongside genuine hazard recalls. We try to surface the severe ones first, but when in doubt, click through to the FDA notice itself for the clinical detail.

10176–10200 of 27206

  • 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-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 (Food)·F-1719-2024·2024-08-14

    Panaderia Guatemex Sheca Anis Bread Recalled for Undeclared Soy Allergen

    Panaderia Guatemex is recalling Sheca Anis bread products due to undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Sheca Anis packaged in plastic bag
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-2497-2024·2024-08-14

    BD PYXIS MEDBANK Medication Cabinet Software Issue Causes Incorrect Bin Labels

    CareFusion is recalling BD PYXIS MEDBANK medication dispensing cabinets due to a software issue that causes incorrect bin information to print on restock labels, potentially leading to medication selection errors.

    Product
    BD PYXIS MEDBANK TWR MN CR-6HH-1FH-3FM-P, REF: 169-92 containing software version 3.9.1.9
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2510-2024·2024-08-14

    Philips IntelliVue Patient Monitors lack critical software monitoring options

    Philips IntelliVue Patient Monitors (models MX400/450/500/550) with software versions L.x or M.x are missing three monitoring capability options (MOS, M06, M20) due to software changes, creating potential for delayed or incorrect treatment. The recall involves 18 units distributed nationwide and internationally.

    Product
    IntelliVue Patient Monitor MX500 with L.x and M.x; K.x provided with L.x entitlements Model Number: 866064. Indicated for use by health care professionals for monitoring and recording of, and to generate alarms for, multiple physiological parameters of adults, pediatrics, and
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1721-2024·2024-08-14

    Panaderia Guatemex Champurradas Recalled for Undeclared Soy

    Panaderia Guatemex is recalling Champurradas due to the presence of undeclared soy allergen. The recall affects 170 bags distributed in Georgia, Kentucky, and Tennessee.

    Product
    Panaderia Guatemex - Champurradas packaged in plastic bag
    Category
    Food
    Distribution
    3 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-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 (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-2530-2024·2024-08-14

    Baxter SIGMA Spectrum Infusion Pump recall due to inadequate pre-release testing

    Baxter Healthcare is recalling the SIGMA Spectrum Infusion Pump (Serial 2158913) distributed nationwide in Florida. The recall is due to improperly performed testing procedures prior to release, which may affect device function.

    Product
    Baxter SIGMA Spectrum Infusion Pump, Product Code: 35700BAX2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2537-2024·2024-08-14

    Medical Device Hookup Instructions Incorrect, Risking Endoscope Disinfection

    Steris Corporation recalls 129 Hookup devices (Model 2-8-540HAN) due to incorrect hookup instructions in product documentation. Using wrong connections may prevent proper endoscope disinfection, creating infection risk.

    Product
    Hookup Model/Catalog Number: 2-8-540HAN 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-2478-2024·2024-08-14

    GE Optima MR360 MRI System Software May Overheat Implants

    GE Optima MR360 MRI systems with affected software versions may exceed safe radiofrequency energy limits, potentially overheating MR-conditional implants when specific imaging sequences are used. 469 units are affected worldwide.

    Product
    Optima MR360, 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-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-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 (Devices)·Z-2476-2024·2024-08-14

    GE SIGNA MR360 MRI System Software Defect May Overheat Implants

    GE SIGNA MR360 MRI systems with software versions SV25.5 or SV25.6 may exceed prescribed RF exposure limits in certain scan configurations, potentially overheating MR-conditional implants. The recall affects 81 units worldwide.

    Product
    SIGNA MR360, with affected software versions: SV25.5, SV25.6; Nuclear Magnetic Resonance Imaging System
    Category
    Medical Device
    Distribution
    0 states
  • 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 (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-2542-2024·2024-08-14

    Olympus Everest Bipolar Cutting Forceps Recalled for Packaging Defects

    Olympus is recalling Everest Bipolar Cutting Forceps due to fractures and breakages in packaging trays and Tyvek covers that may compromise sterility. The recall affects 4,364 units distributed worldwide.

    Product
    The Everest Bipolar Cutting Forceps are intended to be passed through a 5-mm or 10-mm cannula, depending on the model/outer diameter size of the forceps. Coagulation is achieved using electrosurgical energy under visualization. The device is to be used with bipolar outputs of c
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-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-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-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-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