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

23501–23525 of 27699

  • HighFDA (Devices)·Z-1640-2015·2015-05-27

    Richard-Allan Scientific Recalls Mucolexx Mucolytic Agent Due to Fungal Contamination

    Richard-Allan Scientific is recalling Mucolexx mucolytic agent and Mucolexx products after a customer reported fungal contamination in two lots.

    Product
    Lerner Laboratories Mucolexx, 1 pint / 473 ml & 1 gallon/3.8 L; Shandon Mucolexx 500ml/0.13gal, 4L/1.06 gal, 120mL Product Usage: A mucoliquefying preservative designed for use in the preparation of mucoid cytology specimens. Mucolexx & Mucolytic Agent liquefies mucus…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1606-2015·2015-05-20

    GE Healthcare Recalls CARESCAPE Bx50 Monitors for Pacemaker Detection Defect

    GE Healthcare is recalling 110 CARESCAPE Bx50 monitors because they may fail to indicate when pacemaker detection is off, potentially delaying treatment for asystole.

    Product
    GE Healthcare, CARESCAPE Monitor B850, B650 and B450 (Bx50).
    Category
    Medical Device
    Distribution
    3 states
  • SevereFDA (Devices)·Z-1604-2015·2015-05-20

    HeartWare HVAD Pump Driveline Splice Kit Recalled for Failure Risk

    HeartWare Inc is recalling HVAD Pump Driveline Splice Kits because they may fail if exposed to excessive force. The recall affects 35 units distributed in the US and several international countries.

    Product
    HeartWare Ventricular Assist System (HVAD) Pump Driveline Splice Kit Product Usage: Is intended to repair the driveline cable once an electrical break has been identified. These repairs are limited to the portion of the driveline that is outside the patient boundary (exit…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1616-2015·2015-05-20

    Beckman Coulter Recalls DxH Diluent Due to Hemoglobin Chamber Compromise

    Beckman Coulter is recalling specific lots of COULTER DxH Diluent because increased complaints indicate the product may compromise the hemoglobin chamber in certain blood analysis systems.

    Product
    COULTER DxH Diluent, Catalog No. 628017, Part No. A59956. For use as an isotonic buffered diluent in conjunction with a cyanide-free lytic agent for counting and sizing blood cells.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-1599-2015·2015-05-20

    FDA Recalls VenaSeal Vascular Closure Systems Due to Sterility Concerns

    The FDA is recalling VenaSeal vascular closure systems because a possible sterility breach in the outer packaging may compromise the device's sterility.

    Product
    VenaSeal, Sapheon Closure System, Model # SP-101, VS-301 and VS-402. For vascular use.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1598-2015·2015-05-20

    Philips ADAC Vertex Gamma Cameras Recalled for Mechanical Drift Hazard

    Philips Medical Systems is recalling 918 ADAC Vertex Gamma Cameras because detector heads may drift and contact patients during imaging.

    Product
    Nuclear Gamma Cameras (ADAC Vertex Classic, ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60) Philips Medical Systems, Cleveland, OH
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1608-2015·2015-05-20

    Spacelabs qube Compact Monitor Recalled for Power Failure Risk

    Spacelabs Healthcare is recalling five qube Compact Monitors because the input power can fail or the device may not turn on.

    Product
    Spacelabs qube Compact Monitor, Model 91390. The monitor is functioning as either bedside or central monitors; passively displays data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric…
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1611-2015·2015-05-20

    Fujifilm Synapse Cardiovascular Software Recalled for Inaccurate EMR Measurements

    Fujifilm Medical Systems is recalling Synapse Cardiovascular software because measurement values in the EMR may not match clinical reports.

    Product
    FujiMedical Synapse Cardiovascular I ProSolv CardioVascular. A picture Archiving and Communication System Software versions: Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1
    Category
    Medical Device
    Distribution
    17 states
  • HighFDA (Devices)·Z-1613-2015·2015-05-20

    Handicare ReTurn Patient Transfer Belt Recalled for Torn Seams

    Handicare USA is recalling 64 units of ReTurn patient transfer belts because the heat-welded seam on the strap tore when force was applied.

    Product
    ReTurn belt, wipeable, sizes Small through Extra Large, Plastic pouch, 1 item per pouch. Patient transfer aid.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1602-2015·2015-05-20

    Biomerieux Vitek 2 Fungal Susceptibility Cards Recalled for QC Failures

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards due to Out-of-Range-Low Flucytosine QC results for Candida krusei.

    Product
    Vitek 2 AST-YS07 REF 414 967, Fungal Susceptibility Card, 20 cards per carton, IVD. Intended for use with the Vitek 2 Systems in clinical laboratories as an in vitro test to determine the susceptibility of clinically significant yeasts to antifungal agents when used as…
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1574-2015·2015-05-13

    MHI-TM2000 Linear Accelerator System Software Recall for Communication Errors

    Mitsubishi Heavy Industries is recalling 11 MHI-TM2000 Linear Accelerator Systems due to a software defect that allows radiation delivery despite communication errors and prevents saving treatment records.

    Product
    MHI-TM2000 Linear Accelerator System (Software Version 3.5.0 and 3.5.1)
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1586-2015·2015-05-13

    Bard MAX-CORE Biopsy Instruments Recalled for Self-Activation Risk

    Bard Peripheral Vascular Inc is recalling 7,995 Bard MAX-CORE Disposable Core Biopsy Instruments due to a risk of self-activation-related issues.

    Product
    BARD MAX-CORE Disposable Core Biopsy Instrument Gauge x Length 18g x 20cm The BARD MAX-CORE Disposable Core Biopsy Instrument is a single patient use core biopsy device. It is available in several needle gauge sizes and lengths. The side and rear actuator buttons are…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1577-2015·2015-05-13

    Spacelabs Ultraview SL Command Modules Recalled for Random Resets

    Spacelabs is recalling Ultraview SL Command Modules with specific Masimo SpO2 components due to a defect causing random resets.

    Product
    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1573-2015·2015-05-13

    Stryker Recalls Ambulating Bulbs Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling Ambulating Bulbs used with wound drains because of a potential sterility breach in the packaging.

    Product
    Ambulating Bulb Ambulating Bulb: The Ambulating Bulb comprises four main components: the suction reservoir, the PVC tubing, the slide clamp and the female connector. The rigid polycarbonate female connector is used to connect the ambulating bulb to the CBCII evacuator tube in…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling 5,100 units of MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    127" (323cm) Transfer Set w/Check Valve, MicroClave T-Connector, Anti-Siphon Valve, Clamp, Luer Lock, Non-DEHP Tubing, Item No. B33351 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1460-2015·2015-05-13

    Eos Imaging Recalls EOS Digital Radiography Systems Due to Filtration Alert Issue

    Eos Imaging Inc is recalling 13 EOS digital radiography systems because a software alert regarding X-ray beam filtration may be suppressed, potentially leading to improper filtration during exams.

    Product
    EOS, Digital radiography system used in general radiographic examinations.
    Category
    Medical Device
    Distribution
    9 states
  • HighFDA (Devices)·Z-1562-2015·2015-05-13

    Stryker Recalls Trocar Wound Drains Due to Potential Sterility Breach

    Stryker Instruments is voluntarily recalling specific trocar wound drains and ambulating bulbs because of a potential sterility breach in the packaging.

    Product
    3/16 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1595-2015·2015-05-13

    ICU Medical Recalls 98-inch Transfer Sets Due to Connection Separation

    ICU Medical is recalling 50 units of 98-inch Transfer Sets because potential connection separation could lead to leakage.

    Product
    98" (249 cm) Transfer Set w/MicroClave T-Connector, 2 Check Valves, Luer Lock, Non-DEHP Tubing, Item No. B3372 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1564-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    1/8 in. Trocar with Single Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1567-2015·2015-05-13

    Stryker Recalls Wound Drains and Ambulating Bulb for Sterility Breach

    Stryker Instruments is voluntarily recalling specific wound drain and ambulating bulb products due to a potential sterility breach in the packaging.

    Product
    1/4 in. Double Trocar with Wound Drain Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1589-2015·2015-05-13

    ICU Medical Recalls MicroClave T-Connectors Due to Potential Leakage

    ICU Medical is recalling MicroClave T-Connectors because potential connection separation issues could lead to leakage.

    Product
    107" (272 cm) Ext Set w/2 Check Valves, MicroClave T-Connector, Clamp, Rotating Luer, Non-DEHP Tubing, Item No. B33041 Product Usage: IV Administration sets are intended for the infusion and withdrawal of fluids. The devices are provided sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1576-2015·2015-05-13

    B. Braun Medical Recalls Pain Control Trays Due to Sterile Barrier Risk

    B. Braun Medical is recalling specific pain control trays because a potential hole in the outer tray may compromise the sterile barrier, posing a risk of contamination.

    Product
    CONTIPLEX Continuous Peripheral Nerve Block Tray, CONTIPLEX Stirn Continuous Nerve Block Tray, Custom Epidural and Anesthesia Tray, Custom Epidural Anesthesia Tray, Custom Kit, Custom Single Dose Epidural Anesthesia Tray, Custom Spinal Anesthesia Tray, Custom Spinal Epidural…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1568-2015·2015-05-13

    Stryker Recalls Wound Drains for Potential Sterility Breach

    Stryker Instruments is voluntarily recalling CBCII Wound Drains and Ambulating Bulbs due to a potential sterility breach in the packaging.

    Product
    3/16 in. Round Drain with Trocar Curved Trocar with Wound Drain/Double Trocar with Wound Drain: The curved trocar wound drain has a curved metal trocar attached to one end of the flexible wound drain tube. There is also a polymeric trocar guard that provides protection from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2015·2015-05-13

    Philips EPIQ 7 Ultrasound System Recalled for Pediatric BSA Calculation Error

    Philips is recalling EPIQ 7 Ultrasound Systems with the Pediatric Cardiology option because a unit conversion error may cause incorrect Body Surface Area calculations.

    Product
    EPIQ 7 Ultrasound System with Pediatric Cardiology option, Model: EPIQ 7G, EPIC 7C, EPIQ 7W. Catalog Number: 795200 / 795201. Part Number: 989605386721 With: 453561726491 (1.0) 453561728121 (1.0.1) 453561736781 (1.1) 453561750021 (1.1.1) 453561753631 (1.1.2) 453561772251…
    Category
    Medical Device
    Distribution
    Distributed nationwide