The Recall Desk

Severity 3 of 5

High recalls

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

What “high” means here

Severity 3 (High) recalls have a known hazard but no confirmed illness, injury, or property damage in the source text. The risk is theoretical-but-real: a pathogen pre-emptively pulled from shelves before anyone got sick, an allergen mislabeling on an uncommon allergen, a precautionary correction on a device that hasn't yet malfunctioned in the field. Most allergen recalls land here, as do most preventive food recalls based on routine sampling. You should still stop using the product, but you don't need to panic.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

40026–40050 of 50506

  • HighCPSC·15039·2014-12-02

    Daikin Streamer Air Purifiers Recalled for Fire Hazard

    Daikin is recalling Streamer air purifiers because the circuit board can overheat and cause a fire. No injuries have been reported.

    Product
    Daikin Streamer air purifiers
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighNHTSA·14V764000·2014-12-01

    Mercedes-Benz Recalls 2014-2015 Sprinter Vehicles Due to Oil Leak Fire Risk

    Mercedes-Benz is recalling 2014-2015 Sprinter 2500 and 3500 vans because oil may leak from the chain tensioner gasket, posing a fire and road hazard risk.

    Product
    MERCEDES BENZ — MERCEDES BENZ, MERCEDES-BENZ SPRINTER 2500, SPRINTER 3500
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighNHTSA·14V762000·2014-12-01

    Mercedes-Benz Recalls 2014-2015 Models Due to Oil Leak Fire Risk

    Mercedes-Benz is recalling 4,871 vehicles because oil may leak from the chain tensioner gasket, posing a fire and road hazard risk.

    Product
    MERCEDES-BENZ — MERCEDES-BENZ GLK250, ML250, E250
    Category
    Vehicle
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1578-2014·2014-11-26

    Medtronic Recalls Sterile Mouse Bags Due to Sterility Control Issues

    Medtronic Navigation is recalling sterile mouse bags because returned devices may not have been properly examined for damage that could compromise sterility.

    Product
    BAG 9732315 MOUSE STERILE 15 PK
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighNHTSA·14E080000·2014-11-26

    Cycle Gear Recalls Certain Street & Steel and Anarchy Motorcycle Helmets

    Cycle Gear is recalling specific Street & Steel Brotherhood and Anarchy motorcycle helmets that may not meet federal safety standards for impact protection.

    Product
    EQUIPMENT:MOTORCYCLE:HELMETS recall
    Category
    Consumer Product
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1594-2014·2014-11-26

    Medtronic Recalls Non-Invasive Shunt Kits Due to Sterility Control Issues

    Medtronic Navigation is recalling 26,674 non-invasive shunt kits because returned devices were not adequately inspected for damage that could compromise sterility.

    Product
    SHUNT KIT 9733605 NON-INVASIVE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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 (Food)·F-0504-2015·2014-11-26

    Original Soup Man Recalls Lobster Bisque for Undeclared Seafood Allergens

    Original Soup Man is recalling Lobster Bisque due to undeclared shrimp, tilapia, and perch. Consumers should check lot numbers and stop consuming the product.

    Product
    THE ORIGINAL SOUPMAN Lobster Bisque, Net Wt 17 oz (482 g). Product is packed as a tetra pak and ships as a pack of 12 or 6 containers per carton. Distributed exclusively by: SoupMan Inc. Staten Island, NY 10314
    Category
    Food
    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 (Food)·F-0528-2015·2014-11-26

    Saxon Creamery Greenfields Monastery Washed Rind Cheese Recalled for E. coli

    Saxon Cheese LLC is recalling one lot of Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese because the product tested positive for E. coli.

    Product
    Saxon Creamery Greenfields Monastery Washed Rind Wisconsin Handcrafted Cheese, 7 lb wheel. Ingredients: Pasteurized Cow's Milk, culture, salt, enzymes, contains milk. Keep Refrigerated.
    Category
    Food
    Distribution
    1 state
  • 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