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.

12776–12800 of 27206

  • HighFDA (Devices)·Z-0999-2024·2024-02-14

    Surgical hip instruments recalled due to compromised sterility packaging

    Howmedica Osteonics is recalling HRIS ACET CUP surgical instruments used in hip replacement surgery due to failed package seal integrity testing. The recall affects lot-numbered units distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0818-2024·2024-02-14

    Reser's Mashed Red Skin Potatoes recalled due to improper temperature storage

    Reser's Mashed Red Skin Potatoes were not held at appropriate temperatures during distribution in Ohio, New York, and Pennsylvania between November 2023 and January 2024. Improper temperature storage could support pathogen growth and spoilage.

    Product
    RESER'S POTATOE POTATOES MASHED RED SKN 4/5# SUPC/ITEM # 3264
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1014-2024·2024-02-14

    BD Antibiotic Testing Discs Recalled for Accuracy Failures

    Becton Dickinson recalled BD BBL Sensi Disc Augmentin testing discs due to potential accuracy and quality control failures in antibiotic susceptibility testing. Failures may lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Augmentin - 3¿g, Catalog Number 291270¿used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1039-2024·2024-02-14

    BD BBL Sensi Disc Antibiotic Test Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc antibiotic susceptibility test discs due to potential accuracy and quality control failures that may lead to incorrect antibiotic selection and delayed diagnosis.

    Product
    BD BBL Sensi Disc Sulfamethoxazole with Trimethoprim 23.75/1.25 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231536 and 231539¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0847-2024·2024-02-14

    Potato salad recalled due to improper temperature control

    Greco Sidari is recalling Resers potato salad due to improper holding temperature during distribution, risking spoilage and pathogen growth. Affected: 1375 cases in Ohio, New York, and Pennsylvania from November 26 to January 5, 2024.

    Product
    RESERS POTATO SALAD REGULAR 1/8# SUPC/ITEM # 0991p
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1021-2024·2024-02-14

    BD Sensi Disc Cefpodoxime Antibiotic Testing Discs Recalled for Accuracy Failures

    Becton Dickinson is recalling BD BBL Sensi Disc Cefpodoxime testing discs due to potential accuracy failures in antibiotic susceptibility testing. The defect may cause inaccurate results, delayed diagnosis, or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Cefpodoxime - 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231673 and 231674¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1040-2024·2024-02-14

    BD Sensi Disc Tetracycline Recalls Due to Accuracy and QC Failures

    Becton Dickinson & Co. is recalling BD BBL Sensi Disc Tetracycline 30µg laboratory test kits due to potential accuracy and quality control failures in antibiotic susceptibility testing that could lead to delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Tetracycline 30 ug,used for semi-quantitative in vitro susceptibility testing. Catalog Number 230998 and 231344¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1037-2024·2024-02-14

    BD BBL Sensi Disc Piperacillin/Tazobactam Antibiotic Testing Discs Recalled for Accuracy Issues

    BD BBL Sensi Disc Piperacillin/Tazobactam antibiotic susceptibility testing discs are recalled due to potential quality control and accuracy failures. These failures may cause delayed or inaccurate test results, affecting patient diagnosis and antibiotic treatment selection.

    Product
    BD BBL Sensi Disc Piperacillin/Tazobactam- 100/10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231691 and 231692¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0829-2024·2024-02-14

    Fresh Mozzarella Cheese Recalled Due to Temperature Control Issues

    Greco Sidari is recalling fresh bocconcini mozzarella cheese distributed across three states because it was not held at appropriate temperatures. Improper storage could lead to spoilage and potentially support pathogen growth.

    Product
    GRANDE 1.5OZ FRESH BOCCONCINI MOZZ 2/3# SUPC/ITEM # 19132
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0981-2024·2024-02-14

    Insulin Assay Reagent Packs Recalled for Incorrect Unit Conversion

    Beckman Coulter is recalling 19,125 Access Ultrasensitive Insulin reagent packs due to an incorrect unit conversion factor in the assay protocol file. The error could produce inaccurate insulin test results.

    Product
    Access Ultrasensitive Insulin only used on the DxI 9000 Access Immunoassay Analyzer, Catalog Number 33410
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0823-2024·2024-02-14

    Locatelli Cheese Product Recalled for Improper Temperature Storage

    Locatelli Crema Di Locatelli cheese was recalled because it was not held at appropriate temperatures. Improper holding temperatures could affect food safety by supporting spoilage and pathogen growth.

    Product
    LOCATELLI CREMA DI LOCATELLI 4/1.1# SUPC/ITEM # 8926
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0973-2024·2024-02-14

    Ingenia 1.5T Patient Trolley Wheels May Attract to MRI Magnetic Field

    Philips is recalling Ingenia 1.5T patient transportation trolleys with magnetic wheels that could be attracted to MRI magnetic fields. These wheels pose a potential hazard in MRI-equipped facilities when the trolley operates near the magnetic field.

    Product
    Ingenia 1.5T (Product Number 781396) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0984-2024·2024-02-14

    Dual Articulating Headrest May Fail to Lock During Surgery

    Steris Corporation is recalling Dual Articulating Headrests that may fail to lock in position during patient procedures, potentially causing patient injury. Affected units were manufactured between August and October 2023.

    Product
    Dual Articulating Headrest, Velcro P/N P141210813, REF BF753
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1009-2024·2024-02-14

    Water Filter MAJ-2318 May Be Incorrectly Assembled, Risking Infection

    Olympus MAJ-2318 water filters may be assembled incorrectly, allowing unfiltered tap water to contaminate reprocessed endoscopes and expose patients to infection risk.

    Product
    Water Filter MAJ-2318. This MAJ-2318 water filter has been designed to be used with Olympus endoscope reprocessor for prevent contamination of the rinse water. The MAJ-2318 water filter is compatible with OER-ELITE and OER-MINI.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0840-2024·2024-02-14

    Goat Cheese Recalled Due to Improper Temperature Storage Conditions

    Greco Sidari is recalling Norpaco Sweetie Pepper Goat Cheese (1,375 cases, 1/5# units) distributed in Ohio, New York, and Pennsylvania. The cheese was not held at appropriate temperatures, which could support pathogen growth.

    Product
    NORPACO SWEETIE PEPPER GOAT CHEESE 1/5# SUPC/ITEM # 169956
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0982-2024·2024-02-14

    Laboratory Analyzer Software Bug Could Produce Erroneous Clinical Test Results

    Beckman Coulter DxI 9000 immunoassay analyzers may produce erroneous lab results due to software bugs affecting unit conversion and result calculation. Affected devices use software version 1.16 or earlier; 128 devices worldwide are impacted.

    Product
    DxI 9000 Access Immunoassay Analyzer running software version 1.16 or prior,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0827-2024·2024-02-14

    Bel Gioioso Cheese Recalled for Improper Storage Temperature

    Bel Gioioso cheese was not held at appropriate temperatures during distribution, potentially allowing spoilage and pathogen growth. Consumers should not consume affected product.

    Product
    BEL GIOIOSO 12/1# EXACT COMBO SUPC/ITEM # 18304
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1033-2024·2024-02-14

    BD BBL Sensi Disc Meropenem testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Meropenem antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed or incorrect diagnostic results.

    Product
    BD BBL Sensi Disc Meropenem- 10 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231703 and 231704¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1012-2024·2024-02-14

    BD antibiotic susceptibility testing discs recalled for accuracy failures

    Becton Dickinson is recalling BD BBL Sensi Disc Ampicillin antibiotic susceptibility testing discs due to accuracy and quality control failures that may cause delayed diagnosis or inappropriate antibiotic selection.

    Product
    BD BBL Sensi Disc Ampicillin - 10 ¿g, Catalog No. 230705 and 231264; 2 ¿g, Catalog No. 231263. Used for semi-quantitative in vitro susceptibility testing.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1038-2024·2024-02-14

    BD BBL Sensi Disc Rifampin Antibiotic Susceptibility Test Discs Recalled

    BD BBL Sensi Disc Rifampin antibiotic susceptibility test discs are being recalled due to potential accuracy and quality control failures. These discs are distributed domestically nationwide and internationally.

    Product
    BD BBL Sensi Disc Rifampin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231541 and 231544¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0994-2024·2024-02-14

    FilmArray Pneumonia Diagnostic Panel: Potential False Positive Results

    BioFire Diagnostics is recalling the FilmArray Pneumonia Panel diagnostic test kit due to the potential for false positive results. The recall affects 274,290 units distributed worldwide.

    Product
    FilmArray Pneumonia Panel (Pneumo), REF: FIT-ASY-0144, CED 2797, IVD, Rx Only (30 test kit)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0846-2024·2024-02-14

    Potato Salad Recalled for Improper Temperature Storage During Distribution

    Resers Potato Salad Regular is being recalled due to improper temperature storage during distribution, which could potentially support pathogen growth. Affected cases were distributed to Ohio, New York, and Pennsylvania from November 2023 to January 2024.

    Product
    RESERS POTATO SALAD REGULAR 3/8# SUPC/ITEM # 0991C
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-1010-2024·2024-02-14

    PulseSpray Infusion System O-Ring Defect May Cause Medication Leaks

    Angiodynamics is recalling PulseSpray Infusion System devices due to a manufacturing defect in the rotating adaptor O-ring that may compromise seal integrity and cause medication to leak during infusion.

    Product
    PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H787125004235, REF: 12500423.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Drugs)·D-0318-2024·2024-02-14

    FDA Recalls Lansoprazole Delayed-Release Capsules Due to Manufacturing Defects

    The FDA is recalling Lansoprazole Delayed-Release Capsules USP 15 mg due to manufacturing defects including inadequate sealing, capsule damage, and missing product codes. Affected lot 411987 was distributed nationwide.

    Product
    Lansoprazole Delayed-Release Capsules USP, 15 mg, 14-count bottle, Manufactured by: Natco Pharma Limited Kothur- 509 228, India, Distributed by: Rising Pharma Holdings, Inc. East Brunswick, NJ. 08816. NDC 16571-742-41
    Category
    Drug
    Distribution
    Distributed nationwide