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

Category

All categoriesFoodDrugMedical DeviceVehicleConsumer Product

Minimum severity

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

Clear filters

34476–34500 of 40449

  • HighFDA (Devices)·Z-0218-2015·2014-11-26

    Accuray Recalls CyberKnife Robotic Radiosurgery Systems Due to Software Upgrade Issue

    Accuray is recalling 84 CyberKnife Robotic Radiosurgery Systems to correct a potential safety issue related to upgrading the Treatment Delivery Software for the first generation IRIS Variable Aperture Collimator.

    Product
    CyberKnife Robotic Radiosurgery System with the first generation IRIS Variable Aperture Collimator. The CyberKnife is indicated for treatment planning and image guided stereotactic Radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body…
    Category
    Medical Device
    Distribution
    26 states
  • HighFDA (Devices)·Z-1600-2014·2014-11-26

    Medtronic Recalls Tumor Resection Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 Tumor Resection Kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RESECTION KIT 9733607 NON-INVASIVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1590-2014·2014-11-26

    Medtronic Recalls Spine Pedicle Accessory Kits Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 single-use spine pedicle accessory kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PAK 9733497 NAV NIM-SPINE PEDICLE ACC KT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1586-2014·2014-11-26

    Medtronic Recalls Instrument Trackers Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use instrument trackers because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    INSTRUMENT TRACKER 9733533XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1602-2014·2014-11-26

    Medtronic Recalls Single-Use Navigation Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 single-use, disposable navigation devices because returned units were not adequately examined for damage that could compromise sterility.

    Product
    UPGRD PRGM 9734638 ADD AxiEM NAVIGATION
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1579-2014·2014-11-26

    Medtronic Recalls Biopsy Needle Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 biopsy needle kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    BIOPSY NEEDLE KIT, 9733068, PASSIVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0221-2015·2014-11-26

    Elekta MOSAIQ Oncology System Recalled for Dose Rounding Error

    Elekta, Inc. is recalling 15 units of the MOSAIQ oncology information system because a dose rounding error may cause incorrect numeric data to be displayed on printed reports.

    Product
    MOSAIQ Product Usage: MOSAIQ is an oncology information system used to manage workflows for treatment planing and delivery. It supports information flow among healthcare facility personnel and can be used wherever radiotherapy and/or chemotherapy are prescribed.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0215-2015·2014-11-26

    Soma Access Systems Recalls AxoTrack I Sterile Procedure Kits

    Soma Access Systems is recalling 3,530 units of AxoTrack I Sterile Procedure Kits because the sterile packaging may fail before the expiration date.

    Product
    AxoTrack I Sterile Procedure Kit 18G, K1001-18XTW, (24/case labeled for US, 5/case labeled for US, 24/case labeled for EU, 5/case labeled for EU). Sterile Procedure Kit for use AxoTrack enabled Ultrasound Transducer for magnetic needle tracking.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1585-2014·2014-11-26

    Medtronic Recalls Single-Use Ref Frame Driver Kits Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 single-use Ref Frame Driver Kits because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    INST 9731132 KIT CR REF FRAME DRIVER 5PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0235-2015·2014-11-26

    Siemens SimView NT Simulation System Recalled for Movement Control Defect

    Siemens is recalling six SimView NT simulation systems because a rare defect may prevent components from stopping, risking collision with patients or equipment.

    Product
    Siemens SimView NT and SimView NT with IDI simulation system components: Product Usage: The intended use of the Radiation Therapy Simulation system is used for simulation of treatment planning prior to the therapeutic treatment of cancer.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2014·2014-11-26

    Medtronic Recalls Sterile Percutaneous Pins Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile percutaneous pins because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    PIN, 9733236, 150MM, STERILE, PERC REF
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0416-2015·2014-11-26

    MediChoice Folding Walker Recalled Due to Wheel Defects

    Owens & Minor is recalling MediChoice Dual-Release Folding Walkers because the wheels may be loose, too tight, or fall off.

    Product
    MediChoice Dual-Release Folding Walker with 5" wheel
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0224-2015·2014-11-26

    Nidek MC-500 Laser Photocoagulator Recalled for Power Output Failure

    Nidek Inc is recalling 21 MC-500 Multicolor Laser Photocoagulators because the devices may fail to emit laser light or output lower power than programmed during retinal treatment.

    Product
    Nidek MC-500 Multicolor Laser Photocoagulator using software version 2.20. Opthalmic Device. The Nidek Multicolor Laser photocoagulator Model MC-500 is indicated for use in retinal photocoagulation for treatment of ocular fundus diseases.
    Category
    Medical Device
    Distribution
    11 states
  • HighFDA (Devices)·Z-0216-2015·2014-11-26

    Silver Star Brands Recalls Transport Chair and Rollator Due to Wheel Failure

    Silver Star Brands is recalling Transport Chair and Rollator units because the wheel assembly may fail, resulting in damaged wheels.

    Product
    Transport Chair and Rollator in 1, Model HE21630011 Burgundy and HE21630011 Blue. This is a walker/rolling chair. Used to assist injured and infirm people to walk or be ambulatory.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0227-2015·2014-11-26

    Monteris Medical Recalls SideFire Directional Laser Probes Due to Tip Separation

    Monteris Medical is recalling 234 SideFire Directional Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    SideFire Directional Laser Probe, REF: NBP101-01, NBP201-01, NBP301-01, NBP401-01, NBP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-1581-2014·2014-11-26

    Medtronic Recalls Disposable Surgical Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 single-use disposable devices because returned items were not adequately inspected for damage that could compromise sterility.

    Product
    DISP 9730950 STRL SPHERE, 1 PK INSERT
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0219-2015·2014-11-26

    Synthes Recalls Titanium Trochanteric Fixation Nails Due to Assembly Error

    Synthes, Inc. is recalling six sterile titanium trochanteric fixation nails due to incorrect assembly that may compromise bone stability.

    Product
    10 mm/135 degree Titanium Cannulated Trochanteric Fixation Nail 170 MM - Sterile: intended to treat stable and unstable fractures of the proximal femur
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0228-2015·2014-11-26

    Monteris Medical Recalls FullFire Diffusing Tip Laser Probes Due to Tip Separation

    Monteris Medical is recalling 133 FullFire Diffusing Tip Laser Probes because the distal sapphire tip may separate from the probe.

    Product
    FullFire Diffusing Tip Laser Probe, REF: DTP101-01, DTP201-01, DTP301-01, DTP401-01, DTP501-01. These laser probes are part of the NeuroBlate System, a unique collection of MRI-compatible laser devices and accessories that create an MRI guided delivery of precision thermal…
    Category
    Medical Device
    Distribution
    12 states
  • HighFDA (Devices)·Z-0225-2015·2014-11-26

    Medacta MectaLIF Oblique Handle Recalled for Incorrect Laser Marking

    Medacta USA is recalling 32 MectaLIF Oblique Handles because incorrect laser markings could lead to improper device insertion during surgery.

    Product
    The MectaLIF Oblique Handle, model number 03.22.10.0262, is used to insert the MectaLIF oblique spinal cage implants.
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-1583-2014·2014-11-26

    Medtronic Recalls Sterile O-Arm Drapes Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile O-Arm drapes because returned devices were not adequately examined for damage to ensure sterility.

    Product
    DRAPE 9732722 TUBE STERILE O-ARM 20PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2014·2014-11-26

    Medtronic Recalls Patient Tracker Devices Due to Sterility Control Issues

    Medtronic Navigation is recalling single-use Patient Tracker devices because returned units may not have been properly examined for damage to ensure sterility.

    Product
    PATIENT TRACKER 9733534XOM ENT 1PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1580-2014·2014-11-26

    Medtronic Recalls Sterile Drill Bits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 sterile drill bits because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BIT 9733516 2.9mm DRILL STERILE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1599-2014·2014-11-26

    Medtronic Recalls AxiEM Tumor Resonance Packs Due to Sterility Concerns

    Medtronic Navigation is recalling 26,674 AxiEM Tumor Resonance Packs because returned devices may not have been properly examined for damage to ensure sterility.

    Product
    TUMOR RES. PACK 9733553 AxiEM S.M.
    Category
    Medical Device
    Distribution
    Distributed nationwide