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

Agency

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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

33101–33125 of 40449

  • 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
  • ModerateFDA (Devices)·Z-1615-2015·2015-05-20

    Siemens Dimension Chemistry Systems Recalled for Non-Standard Power Plugs

    Siemens Healthcare Diagnostics is recalling certain Dimension Integrated Chemistry Systems installed with non-standard power plugs due to a potential electrical hazard.

    Product
    Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimension RxL Max HM, Dimension Xpand, Dimension Xpand HM, Dimension Xpand Plus, Dimension Xpand Plus HM. The Dimension EXL clinical chemistry system is a discrete…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1603-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

    Biomerieux Inc is recalling Vitek 2 Fungal Susceptibility Cards because they produce Out-of-Range-Low Flucytosine QC results for Candida krusei. The affected products were distributed to foreign subsidiaries and distributors.

    Product
    Vitek 2 AST-YS01 REF 22 108, 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
  • ModerateFDA (Devices)·Z-1600-2015·2015-05-20

    Synthes Recalls TFNA Proximal Femoral Nails Due to Locking Mechanism Defect

    Synthes, Inc. is recalling 8,175 TFNA Proximal Femoral Nails because the locking mechanism was assembled too close to the top, potentially causing surgical delays.

    Product
    TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1605-2015·2015-05-20

    BioHorizons Recalls Tapered HD Upgrade Set Due to Incorrect Drill Component

    BioHorizons is recalling 48 units of the Tapered HD Upgrade Set because they were packaged with a stainless steel drill instead of the correct titanium component.

    Product
    Tapered HD Upgrade Set, REF TSKHDUS, Non-Sterile, Rx Only, Product Usage Usage: Surgical instruments used in preparation for dental implant placement
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1601-2015·2015-05-20

    Biomerieux Recalls Vitek 2 Fungal Susceptibility Cards Due to QC Errors

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

    Product
    Vitek 2 AST-YS06 REF 412 610, 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
  • ModerateFDA (Devices)·Z-1607-2015·2015-05-20

    Philips Recalls Nuclear Gamma Cameras Due to Collimator Misalignment

    Philips Medical Systems is recalling 975 nuclear gamma cameras because the collimator exchange carriage and storage cabinet were misaligned.

    Product
    Nuclear gamma cameras (ADAC VERTEX PLUS/SOLUS/CARDIO, ADAC VERTEX V60 & ADAC CARDIO C60) Nuclear gamma cameras intended to produce images depicting the anatomical distribution of single photon and positron emitting radioisotopes with the human body for interpretation by…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1612-2015·2015-05-20

    Fujifilm Synapse Cardiovascular Software Recall for Patient Demographic Mismatch

    Fujifilm Medical Systems is recalling Synapse Cardiovascular software versions v4.0.8 and v4.0.8 SR1 because patient demographics in exported reports may not match the clinical reports.

    Product
    Fujifilm Synapse Cardiovascular I ProSolv CardioVascular Synapse Cardiovascular v4.0.8 Synapse Cardiovascular v4.0.8 SR1 Intended Use: Picture Archiving and Communication System Computer, Diagnostic, Programmable
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1614-2015·2015-05-20

    Stryker Recalls 80 mm Kinemax Stem Extenders Due to Mislabeling

    Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.

    Product
    Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1610-2015·2015-05-20

    Zimmer Hemovac Mini Evacuator Recalled for Missing Instructions for Use

    Zimmer Surgical Inc is recalling 36 units of the 100 mL Hemovac Mini Evacuator because the shipper carton contained only one Instructions for Use (IFU) instead of one per sales unit.

    Product
    Zimmer 100 mL Hemovac Device Hemovac Mini Evacuator. 00-2568-000-10. Zimmer Surgical, Inc. Intended for post-operative collection of wound drainage.
    Category
    Medical Device
    Distribution
    8 states
  • LowFDA (Devices)·Z-1596-2015·2015-05-20

    Arc Medical Recalls ThermoFlo 1 HME Due to Incorrect Outer Carton Expiry Date

    Arc Medical Inc is recalling 1,810 units of ThermoFlo 1 HME because the outer shipping carton displayed an incorrect expiry date, although the inner product carton was labeled correctly.

    Product
    ThermoFlo 1 HME, Disposable, Non-sterile, Expiry date 04/17. Used as a humidifier in a breathing circuit.
    Category
    Medical Device
    Distribution
    2 states
  • LowFDA (Devices)·Z-1597-2015·2015-05-20

    Spinal Elements Mercury Lordosed Rods Recalled for Missing Traceability Markings

    Spinal Elements, Inc. is recalling 588 Mercury lordosed rods because some lack required product identification markings, interrupting device traceability.

    Product
    Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of screws, hooks, rods, connectors, and staples that are used for attachment to the non-cervical spine. Rods span the distance between screws and hooks and achieve…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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