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.

12801–12825 of 27206

  • 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 (Devices)·Z-0995-2024·2024-02-14

    Globus Medical Cranial Drills recalled for sterility loss and discoloration

    Globus Medical is recalling Cranial Drills (2.40mm) due to packaging breaches that may compromise sterility and discoloration near the drill tip. Distributed worldwide.

    Product
    Globus Medical Cranial Drill with Stop, 2.40mm - Instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref : 6143.1834S
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0985-2024·2024-02-14

    Carter-Thomason CloseSure Surgical Kit Recall: Mislabeled Component Descriptions

    CooperSurgical is recalling Carter-Thomason CloseSure System XL surgical kits due to incorrect component descriptions on packaging. The affected batch includes 127 boxes (381 total kits) with lot number 326728.

    Product
    Box as labeled: Regard, Carter-Thomason CloseSure System XL, REF 733776, Quantity 1 Box of 3 Systems. Kit as labeled: Regard, Carter-Thomason CloseSure System, REF 733776, Contents: One (1) Carter-Thomason Suture Passer, One (1) 5 mm Pilot Guide, One (1) 10/12 mm Pilot Guide.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0861-2024·2024-02-14

    Wegmans Mini Danish Recalled for Undeclared Soy Lecithin

    Wegmans Food Markets recalls 9 oz 10-pack Assorted Mini Danish pastries (UPC 7789050815) because the product contains undeclared soy lecithin, which poses a risk to consumers with soy allergies.

    Product
    9 oz 10pk Assorted Mini Danish, bakery box with clear top (UPC 7789050815)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-1000-2024·2024-02-14

    Hip Arthroplasty Surgical Instruments Recalled for Sterile Barrier Failure

    Howmedica Osteonics Corp. is recalling hip arthroplasty surgical instruments after their sterile packaging failed integrity testing. Units with compromised packaging were distributed worldwide.

    Product
    HRIS ACET CUP CUT TIP 32X140 Part Number: 6210-5-200rker. single-use, sterile surgical instruments used during hip arthroplasty
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1055-2024·2024-02-14

    Philips Spectral CT 7500 software issue causes incorrect image labeling

    Philips Spectral CT 7500 imaging devices contain a software defect that can incorrectly label captured images, potentially causing misdiagnosis and incorrect treatment. Affected units total 33 in the US and 177 worldwide.

    Product
    Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1027-2024·2024-02-14

    BD antibiotic susceptibility test disc accuracy failures may affect H. influenzae diagnosis

    Becton Dickinson is recalling antibiotic susceptibility test discs due to quality control failures that may produce inaccurate results. These failures could delay diagnosis and lead to inappropriate antibiotic selection for H. influenzae infections.

    Product
    BD BBL Sensi Disc Ciprofloxacin- 5 ug, used for semi-quantitative in vitro susceptibility testing. Catalog Number 231657¿and 231658¿
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0845-2024·2024-02-14

    Marburger Heavy Cream Recalled for Improper Temperature Storage

    Greco Sidari is recalling 1,375 cases of Marburger 40% Heavy Cream due to improper temperature storage that could support pathogen growth. The product was distributed to Ohio, New York, and Pennsylvania between November 26, 2023, and January 5, 2024.

    Product
    MARBURGER 40% HEAVY CREAM 1/32OZ SUPC/ITEM # 039127P
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0988-2024·2024-02-14

    Anesthesia System Cybersecurity Vulnerability Poses Denial of Service Risk

    The Flow-i C30 Anesthesia System contains a cybersecurity vulnerability allowing remote attackers to cause denial of service, tampering, or code execution, potentially creating hazardous conditions.

    Product
    Flow-i C30 Anesthesia System, model 6677300
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0860-2024·2024-02-14

    Wegmans Chocolate Croissants Recalled for Undeclared Soy Lecithin

    Wegmans has recalled chocolate croissants containing undeclared soy lecithin due to allergen risk. The recall affects 10,338 units distributed across nine states.

    Product
    5 oz 2pk Chocolate Croissant, bakery box with clear top (UPC 7789050655) and Chocolate Croissant 2 oz, bakery box with clear top (UPC 7789048398)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Food)·F-0819-2024·2024-02-14

    Garlic-Stuffed Olive Product Recalled Due to Temperature Control Failure

    Greco Sidari is recalling Norpaco garlic-stuffed olives because they were not held at proper temperatures, which could allow spoilage and pathogenic growth. The recall covers 1,375 cases distributed in Ohio, New York, and Pennsylvania.

    Product
    Norpaco GARLIC STUFF OLIVE 1/7.5# SUPC/ITEM # 3461
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0842-2024·2024-02-14

    Ricotta Cheese Recalled Due to Improper Temperature Storage

    Grande Ricotta Sopraffina (1375 cases) distributed across Ohio, New York, and Pennsylvania from November 2023 to January 2024 is recalled because it was not held at appropriate temperatures, which could support pathogen growth.

    Product
    GRANDE RICOTTA SOPRAFFINA GRANDE 1/3# SUPC/ITEM # 195351
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0843-2024·2024-02-14

    Imported Sharp Provolone Cheese Recalled for Temperature Control Failure

    Greco Sidari is recalling Auricchio imported sharp provolone cheese that was not held at appropriate temperatures, which could promote pathogen growth. The recall affects 1,375 cases distributed to Ohio, New York, and Pennsylvania from November 2023 through January 2024.

    Product
    AURICCHIO IMP SHARP PROV CHEESE 1/17# SUPC/ITEM # 197110
    Category
    Food
    Distribution
    3 states
  • HighFDA (Food)·F-0855-2024·2024-02-14

    Fresh noodle products recalled for undeclared wheat allergen

    Alfred Louie Inc is recalling Pan Fry and Deep Fry Fresh Noodles due to undeclared wheat allergen from enriched flour sub-ingredients. 550 cases distributed in California are affected.

    Product
    Pan Fry Noodle Fresh Noodles, Alfred Louie, Inc. 24 Lb. cartons, Keep Refrigerated. Deep Fry Noodle Fresh Noodles, Alfred Louie, Inc. 40Lb cartons, Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-0862-2024·2024-02-14

    Wegmans Petite Pastry Tray recalled for undeclared soy lecithin

    Wegmans is recalling 24ct Petite Pastry Tray croissants due to undeclared soy lecithin. The affected products were distributed across nine states from New York to North Carolina.

    Product
    24ct Petite Pastry Tray, plastic tray with white base and clear lid (not a scale label) (UPC: UPC 7789034215)
    Category
    Food
    Distribution
    9 states
  • HighFDA (Devices)·Z-0974-2024·2024-02-14

    Patient Transportation System Recalled for Magnetic Wheel MRI Interference Risk

    Philips is recalling Ingenia Elition X patient transportation systems due to magnetic wheels that may be attracted to MRI systems, posing a patient safety risk if used in MRI environments.

    Product
    Ingenia Elition X (Product Number 781358) - HA FlexTrak II (Accessory Number 989710008732), patient transportation system
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0854-2024·2024-02-14

    Seasoned mushroom product recalled due to improper processing procedures

    Ito-Shoten Seasoned Mushroom is recalled due to lack of filed thermal processing procedures. The product was distributed to CA, NJ, IL, TX, and HI.

    Product
    Ito-Shoten Seasoned Mushroom 200g/7.06 oz. Product of Japan Distributed by Mitsuwa Corporation Torrance, CA 90501
    Category
    Food
    Distribution
    5 states
  • HighFDA (Devices)·Z-1003-2024·2024-02-14

    Siemens Atellica CH Immunoglobulin M Reagent Quality Control Bias

    Siemens is recalling 7,075 units of its Total Immunoglobulin M diagnostic reagent due to potential negative bias in quality control and patient sample results. This could affect the accuracy of test results.

    Product
    Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-0838-2024·2024-02-14

    Bel Gioioso Asiago Cheese Recalled for Temperature Storage Failure

    Bel Gioioso Pepato Asiago cheese was not held at appropriate temperature, which could support pathogen growth. Affected products were distributed in Ohio, New York, and Pennsylvania from November 26, 2023 to January 5, 2024.

    Product
    BEL GIOIOSO PEPATO ASIAGO CON PEPPERCORN 10-8OZ SUPC/ITEM # 53478
    Category
    Food
    Distribution
    3 states
  • HighFDA (Devices)·Z-0979-2024·2024-02-14

    Barco MDSC-8527 NXF Medical Display decoder functionality blocked

    Barco is recalling MDSC-8527 NXF medical displays due to I2C cable defects in manufacturing that block the MNA decoder functionality. The recall affects a limited batch distributed in New Jersey.

    Product
    Barco MDSC-8527 NXF, Part Number K9352421
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0320-2024·2024-02-14

    Hydralazine Hydrochloride Tablets Recalled Due to Failed Purity Tests

    Amerisource Health Services is recalling HydrALAZINE Hydrochloride Tablets (10 mg) due to failed impurity specifications discovered during 6-month stability testing.

    Product
    HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 68084-447-01; NDC Unit Dose: 68084-447-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Food)·F-0837-2024·2024-02-14

    Galbani Domestic Mascarpone recalled due to improper storage temperature

    Galbani Domestic Mascarpone (1/5# cases) distributed in Ohio, New York, and Pennsylvania is recalled due to improper temperature storage. The temperature control failure could affect product spoilage and potentially support pathogen growth.

    Product
    GALBANI DOMESTIC MASCARPONE 1/5# SUPC/ITEM # 19641
    Category
    Food
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-1004-2024·2024-02-14

    Olympus Paparella-Type Vent Tube Recall: Missing Expiration Date on Inner Packaging

    Olympus Corporation of the Americas is recalling one lot of Paparella-Type Vent Tubes due to missing expiration date on the inner package, though the date is present on the outer packaging.

    Product
    Olympus/Gyrus Paparrela-Type Vent Tube 1.02MM, Silicone, Sterile- to ventilate the middle ear subsequent to otitis media Model: 240044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0314-2024·2024-02-14

    Prescription Drug Febuxostat Recalled Due to Manufacturing Practice Violations

    Amerisource Health Services LLC is recalling approximately 1,932 cartons of Febuxostat (40 mg tablets) nationwide due to deviations from current good manufacturing practices. The firm initiated the recall voluntarily on January 25, 2024.

    Product
    FEBUXOSTAT — FEBUXOSTAT (FEBUXOSTAT)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0312-2024·2024-02-14

    FDA Recalls Glimepiride Tablets for Misprint on Tablet

    Dr. Reddy's Laboratories is recalling Glimepiride 1mg tablets due to a misprint on the tablet. The recall affects 59,336 bottles distributed nationwide.

    Product
    GLIMEPIRIDE — GLIMEPIRIDE (GLIMEPIRIDE)
    Category
    Drug
    Distribution
    Distributed nationwide