The Recall Desk

Recalls

All US Product Recalls

Searchable archive of product recalls from the FDA, USDA FSIS, CPSC, NHTSA, and EPA — translated into plain English, severity-scored from objective criteria, and always linked back to the original government notice.

How to read this listing

Every recall on this list has been scored 1–5 against an objective rubric from the agency’s own classification, presence of reported injuries or deaths, distribution scope, and hazard type. The colored severity badge on each card is the score — 5 (Critical) means the agency’s own highest classification or reported deaths or serious injuries, 4 (Severe) means significant injury or hospitalization risk, and 3 (High) means a known hazard with no confirmed harm yet. Filter to 3+ (High and above) if you want to skip routine Class-III notices.

The agency chips above control which streams are visible. FDA spans food, drugs, and medical devices. USDA FSIS is meat, poultry, and processed egg products. CPSC is household consumer products. NHTSA is vehicles, tires, and child seats. Nationwide on a card means the recall affects every US state — most do — while a state list means distribution was limited.

Click any recall to see the full summary, affected lot codes and model numbers, the agency’s own classification, and a direct link back to the original government notice for verification.

Filters

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All agenciesFDA (Food)FDA (Drugs)FDA (Devices)USDA FSISCPSCNHTSAEPA

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All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

12451–12475 of 40095

  • HighFDA (Devices)·Z-1079-2022·2022-05-25

    FDA Updates EXALT Duodenoscope Instructions for Known Perforation Risk

    Boston Scientific's EXALT Model D duodenoscope is subject to updated use instructions addressing a known risk of perforation. The FDA requires updated guidance on insertion and removal procedures.

    Product
    EXALT Model D Single- Use Duodenoscope (Box 1) UPN: M00542420 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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1106-2022·2022-05-25

    HeartWare Ventricular Assist Device recalled for translation errors

    Heartware, Inc. is recalling the HeartWare Ventricular Assist Device (HVAD) in Finland and Turkey due to translation errors in device displays and supporting documentation that could impair proper device operation.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, Model Number 1521DE, MONITOR 1521DE EXPLORE TECH
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1087-2022·2022-05-25

    MicroScan WalkAway-40 Medical Instruments Recalled for Incorrect Power Connector Rating

    Three MicroScan WalkAway-40 medical instruments were recalled because they have an AC power connector rated at 1 ampere instead of the correct 10 ampere rating. This mismatch poses a potential electrical and fire hazard.

    Product
    MicroScan WalkAway-40 plus Reconditioned Instrument REF B1018-340R
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1099-2022·2022-05-25

    Smith & Nephew knee implants recalled for labeling error

    Smith & Nephew is recalling knee implants shipped in incorrect packaging—a JOURNEY II femoral implant was boxed as a LEGION NARROW PS implant. The labeling error could result in the wrong implant being used during surgery.

    Product
    LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1117-2022·2022-05-25

    Portable Oxygen Concentrator Recalled for Lack of FDA Clearance

    Caire, Inc. is recalling two CAIRE FreeStyle Comfort portable oxygen concentrators because they were not cleared by the FDA for U.S. distribution. The affected devices were distributed to Puerto Rico.

    Product
    CAIRE FreeStyle Comfort Portable Oxygen Concentrator with autoSAT, UltraSense and autoDOSE, model #AS200-3
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1093-2022·2022-05-25

    NaviCare Nurse Call System: Firmware Memory Leak in Supplier Component

    Baxter Healthcare is recalling 11,028 NaviCare Nurse Call Systems distributed in North Carolina and Virginia due to a firmware memory leak in a supplier-manufactured component.

    Product
    NaviCare 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-1100-2022·2022-05-25

    Affinity Dental Impression Material Recalled for Wrong Material

    Clinician's Choice Dental Products is recalling Affinity Hydroactive Impression Material Heavy Body Regular Set because Template Ultra Quick matrix Material was packaged instead of the indicated Heavy Body viscosity. The recall affects 46 units distributed in South Carolina.

    Product
    Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via impression, a reproduction of tooth and gum structure. Product ID: 013912
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1084-2022·2022-05-25

    Medical Device Maker Recalls Laboratory Instrument With Incorrect Power Connector Rating

    Beckman Coulter Inc. is recalling 7 MicroScan WalkAway-96 plus instruments due to an AC power connector rated for 1 ampere instead of the required 10 amperes. The underated connector could fail or overheat during normal operation.

    Product
    MicroScan WalkAway-96 plus Instrument REF B1018-284
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1107-2022·2022-05-25

    HeartWare HVAD Ventricular Assist Device Recalled for Translation Errors

    HeartWare is recalling 645 units of HVAD Ventricular Assist Device documentation due to translation errors in Finnish and Turkish. The errors affect controller displays, patient manuals, and emergency responder guides.

    Product
    HeartWare Ventricular Assist Device (HVAD) System, individual pamphlets: HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide (FI-Finnish) HVAD¿ System Emergency Responder Guide…
    Category
    Medical Device
    Distribution
    0 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 (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 (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 (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