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.

24351–24375 of 88183

  • HighFDA (Devices)·Z-1089-2022·2022-05-25

    Acetaminophen tablets in first aid kits recalled for contamination risk

    Total Resources International first aid kits containing acetaminophen tablets are being recalled due to potential cross-contamination from manufacturing equipment damage at the tablet supplier.

    Product
    Total Resources International First Aid Kits, Item Numbers: 10HBC01087, 10HBC01092A3PK, 10HBC01112, 10HBC01113, 10HBC01329GLRV1, 10OUT02086GLRV2, 16BLU01495, 20HBC01015CCREV3, 20HBC01084GLOWCC. Kit contents include ULTRAtab Laboratories Coated APAP 325 mg (Acetaminophen 325…
    Category
    Drug
    Distribution
    30 states
  • HighFDA (Devices)·Z-1091-2022·2022-05-25

    ATLAS Stim Headbox Recalled: Unapproved Investigational Device Without Safety Testing

    Neuralynx is recalling the ATLAS Stim Headbox, a neurophysiology device distributed without FDA investigational approval or electrical safety clearance.

    Product
    ATLAS Stim Headbox-NK For use only with the ATLAS Neurophysiology System. CAUTION--INVESTIGATIONAL DEVICE Limited by Federal (or United States) law to investigational use. Only for use in Non-Significant Risk studies under the supervision of an IRB.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1085-2022·2022-05-25

    Medical diagnostic instrument recalled for electrical connector assembly defect

    Beckman Coulter is recalling 40 DxM 1040 MicroScan WalkAway laboratory instruments due to an assembly defect: some units have an AC power connector inlet rated at 1 ampere instead of the correct 10-ampere rating, which could impair power delivery.

    Product
    DxM 1040 MicroScan WalkAway Instrument REF B1018-440
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1094-2022·2022-05-25

    Nurse Call System Recall Due to Firmware Memory Leak

    Baxter Healthcare is recalling 1,414 Voalte Nurse Call System units distributed to North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.

    Product
    Voalte Nurse Call System provides a comprehensive communication and information system that places patient calls, staff calls, and emergency calls.
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-1116-2022·2022-05-25

    Olympus Uretero-reno Videoscope Bending Section May Crack and Deform

    The bending section of the Olympus URF-V2 videoscope may crack and develop abnormal shape or angulation. This could affect the device's function during urological procedures.

    Product
    Olympus Uretero-reno videoscope, Model No. URF-V2
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1105-2022·2022-05-25

    HeartWare HVAD Controller: Translation Errors in Critical Documentation

    The FDA is recalling 59 units of HeartWare HVAD System Controller due to translation errors in Finnish and Turkish in device displays and critical documentation including patient manuals and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1420-Controller 2.0
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1112-2022·2022-05-25

    VITROS Immunodiagnostic Hormone Reagents Recalled for Measurement Imprecision

    Specific lots of VITROS FSH, LH, and Prolactin reagent kits may produce falsely high or delayed test results at low measurement levels. Affected lots distributed worldwide; labs should discontinue use and contact the manufacturer.

    Product
    VITROS Immunodiagnostic Products FSH Reagent Pack- IVD 1931922
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1114-2022·2022-05-25

    VITROS Prolactin Reagent Recalled for Low-End Measurement Imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Prolactin Reagent packs due to low-end measurement imprecision that may cause falsely high or delayed test results. Approximately 1,767 affected units are distributed worldwide.

    Product
    VITROS Immunodiagnostic Products Prolactin Reagent Pack Product Code: 1849793
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1096-2022·2022-05-25

    BioPlex 2200 CMV IgM Reagent Pack Recalled for Variable Test Performance

    Bio-Rad Laboratories recalls the BioPlex 2200 ToRC IgM Reagent Pack (Lot 301388) due to CMV IgM analyte showing variable elevated background levels depending on reagent handling.

    Product
    BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1062-2022·2022-05-25

    Milk & Dark Chocolate Himalayan Salted Caramels Recalled for Undeclared Soy

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Himalayan Salted Caramels distributed in Washington because product labels do not disclose soy lecithin, a major allergen.

    Product
    Milk & Dark Chocolate Himalayan Salted Caramels. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11804 7.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1102-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 236 units of HVAD ventricular assist devices due to Finnish and Turkish translation errors in controller displays, instructions, and patient materials distributed in Finland and Turkey.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Pump Implant Kit, Model Number1104
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Food)·F-1064-2022·2022-05-25

    Milk and Dark Chocolate Caramels Recalled for Undeclared Soy Lecithin

    R & S Roberts Enterprises recalls Milk & Dark Chocolate Caramel Macchiato candies distributed in Washington due to undeclared soy lecithin. Consumers with soy allergies should not consume the product.

    Product
    Milk & Dark Chocolate Caramel Macchiato. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. UPC 7 82565 11777 4.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Food)·F-1065-2022·2022-05-25

    Milk & Dark Chocolate Healthy Bites Recalled for Undeclared Soy

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Healthy Bites due to undeclared soy lecithin. Products were manufactured on 03/11/2022 and distributed in Washington.

    Product
    Milk & Dark Chocolate Healthy Bites. Chocolate coated caramels packaged in bulk and distributed in bulk to the firm's stores in a bin. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Drugs)·D-0869-2022·2022-05-25

    Acetaminophen Oral Solution Recalled Due to Manufacturing Quality Control Failure

    Plastikon Healthcare LLC is recalling Acetaminophen Oral Solution due to failure to properly investigate failed microbial testing. The recall affects 121,800 unit dose cups distributed in Indiana.

    Product
    Acetaminophen Oral Solution, USP 650mg/ 20.3 mL cup, packaged in 10 cups per tray, 10 trays per carton, For Institutional Use Only, Distributed by Major Pharmaceuticals, Livonia, MI 48152, NDC: 0904-6820-76.
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Food)·F-1074-2022·2022-05-25

    Turkey Hill Chocolate Marshmallow Ice Cream Recalled for Undeclared Peanuts

    Turkey Hill is recalling 48-ounce packages of Chocolate Marshmallow Premium Ice Cream sold in Pennsylvania due to undeclared peanuts. Consumers with peanut allergies should not consume this product.

    Product
    Chocolate Marshmallow Premium Ice Cream, 48 ounce, Paper Carton and Paper Lid, 6 units per shrink-wrapped pack. Keep Frozen. UPC code: 020735420935.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1111-2022·2022-05-25

    Turbett Surgical Container TS1500 weld failures breach sterile barrier

    The Turbett Surgical Container TS1500 is being recalled because eight units manufactured before June 2019 have exhibited weld failures that breach the sterile barrier during prolonged use.

    Product
    Turbett Surgical Container, TS1500
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1113-2022·2022-05-25

    FDA Recalls VITROS Immunodiagnostic LH Reagent Pack for measurement imprecision

    Ortho-Clinical Diagnostics is recalling VITROS Immunodiagnostic Products LH Reagent Pack due to low-end imprecision that may produce falsely high or delayed patient and quality control results.

    Product
    VITROS Immunodiagnostic Products LH Reagent Pack Product Code: 1350198
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1115-2022·2022-05-25

    Radiometer Arterial Blood Sampler recalled due to sterility guarantee loss

    Radiometer Medical is recalling Arterial Blood Samplers (REF:956-552) because sterility cannot be guaranteed throughout the product's shelf life. The recall affects 7,228 boxes distributed worldwide.

    Product
    Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0874-2022·2022-05-25

    Pfizer Accupril Blood Pressure Tablets Recalled for Nitrosamine Contamination

    Pfizer is recalling specific lots of Accupril (quinapril HCl) 40 mg tablets distributed nationwide and in Puerto Rico because the product contains N-nitrosoquinapril above acceptable limits, a manufacturing deviation.

    Product
    Accupril (Quinapril HCl Tablets) 40 mg, 90 Tablets, Rx only NDC 0071-0535-23 Distributed by: Parke-Davis Division of Pfizer Inc. NY, NY 10017
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Food)·F-1066-2022·2022-05-25

    Chocolate Sea Salt Caramels Recalled for Undeclared Soy Lecithin

    R & S Roberts Enterprises is recalling Milk & Dark Chocolate Sea Salt Healthy Bites because product labels do not declare soy lecithin used in the canola oil spray releasing agent. No illnesses have been reported.

    Product
    Milk & Dark Chocolate Sea Salt Healthy Bites. Chocolate coated caramels packaged bulk for stores. No UPC.
    Category
    Food
    Distribution
    1 state
  • HighFDA (Devices)·Z-1083-2022·2022-05-25

    MicroScan WalkAway-40 plus Instrument recalled for incorrect AC power connector

    Beckman Coulter is recalling 22 MicroScan WalkAway-40 plus Instruments with an AC power entry connector rated at 1 ampere instead of the correct 10 amperes, creating a potential electrical hazard.

    Product
    MicroScan WalkAway-40 plus Instrument REF B1018-283
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1082-2022·2022-05-25

    EXALT Model D Single-Use Duodenoscope: Updated Instructions for Perforation Risk

    Boston Scientific issued updated instructions for the EXALT Model D Single-Use Duodenoscope to highlight the known risk of perforation and provide best practices for safe insertion, advancement, and removal.

    Product
    EXALT Model D Single-Use Duodenoscope (Box 2) UPN: M0054242CE1 Intended Use: sterile, single-use, flexible video duodenoscope intended for use with the EXALT" Controller to examine duodenum and perform various procedures within the duodenum including endoscopy and endoscopic…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1108-2022·2022-05-25

    VitriGuard Cryopreservation Storage Device Recalled for Sterility Risk

    CooperSurgical is recalling 2,340 VitriGuard cryopreservation devices with compromised barrier seals that may compromise sterility. The affected devices were distributed across ten U.S. states.

    Product
    VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
    Category
    Medical Device
    Distribution
    10 states
  • HighFDA (Food)·F-1070-2022·2022-05-25

    Gorton's Fish Sandwich Fillets Recalled Due to Bone Fragments

    Gorton's is recalling Fish Sandwich Fillets (18.3 oz) because they may contain large and/or sharp fish bones that could pose a choking hazard or cause injury.

    Product
    Gorton s Fish Sandwich Fillets, 18.3 OZ, UPC 44400 15440
    Category
    Food
    Distribution
    6 states
  • HighFDA (Food)·F-1073-2022·2022-05-25

    SE Grocers Cheesecake Sampler Recalled for Missing Pecan Allergen Declaration

    SE Grocers Cheesecake Sampler is recalled because pecans are not declared on the ingredient label, despite being processed during manufacturing, creating a risk for consumers with pecan allergies.

    Product
    SE Grocers Cheesecake SAMPLER New York Style, Chocolate Silk, Strawberry Swirl, Turtle - NO ARTIFICIAL FLAVORS - NET WT 32 OZ (2 LB) 907g - UPC 0 38259 13495 5 CONTAINS: EGG, MILK, SOY, AND WHEAT. MANUFACTURED IN A FACILITY THAT ALSO PROCESSES PEANUTS, TREE NUTS (ALMONDS…
    Category
    Food
    Distribution
    2 states