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.

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27126–27150 of 40357

  • ModerateFDA (Devices)·Z-1765-2017·2017-04-19

    Ortho-Clinical Diagnostics Recalls VITROS NT-proBNP Reagent Packs Due to Calibration Failures

    Ortho-Clinical Diagnostics is recalling VITROS NT-proBNP Reagent Packs because background signals are increasing, causing calibration failures.

    Product
    VITROS Immunodiagnostic Products NT-pro BNP Reagent Pack, REF/Catalog 680 2156, IVD --- Ortho-Clinical Diagnostics Pencoed, Bridgend CF35 5PZ, UK
    Category
    Medical Device
    Distribution
    1 state
  • ModerateFDA (Devices)·Z-1804-2017·2017-04-19

    2k Innovations Recalls Volt Resistance Heated Therapy Shoulder Wrap

    2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Shoulder Wraps because the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Heated Therapy Shoulder Wrap Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1755-2017·2017-04-19

    Zimmer Biomet Recalls MEDTECH ROSA Spine Software Due to Unapproved Change

    Zimmer Biomet is recalling MEDTECH ROSA Spine 1.0.2 software because an unapproved change was made by the supplier. The device is used to guide instruments during spine surgery.

    Product
    MEDTECH ROSA Spine 1.0.2 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments during spine surgery. Guidance is based on an intra-operative plan developed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1782-2017·2017-04-19

    GE Healthcare Recalls Centricity PACS Web Diagnostic Software

    GE Healthcare is recalling 118 units of Centricity PACS Web Diagnostic software due to a defect where study category labels and hanging positions appear incorrectly swapped.

    Product
    Centricity PACS Web Diagnostic (WebDX) by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources within the system or across computer networks at distributed locations.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1809-2017·2017-04-19

    2k Innovations Recalls Volt Heated Socks for Unapproved Medical Claims

    2k Innovations is recalling Volt Resistance Heated Socks because FDA inspections found the product makes unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Socks (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1805-2017·2017-04-19

    Volt Resistance Heated Therapy Foot Wrap Recalled for Unapproved Medical Claims

    2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Therapy Foot Wraps because FDA inspections found unapproved therapy and medical claims on product information and the company website.

    Product
    Volt Resistance Heated Therapy Foot Wrap Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1766-2017·2017-04-19

    Merit Medical Recalls PreludeSYNC Radial Compression Devices Due to Valve Seal Defect

    Merit Medical Systems is recalling 1,940 PreludeSYNC Radial Compression Devices because manufacturing particulates may prevent the inflation valve from sealing completely.

    Product
    The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1803-2017·2017-04-19

    FDA Recalls 2k Innovations Heated Lower Back Garment for Unapproved Claims

    2k Innovations Inc. is recalling 22,757 Volt Resistance Heated Lower Back Garments because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Heated Lower Back Garment Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1775-2017·2017-04-19

    Volcano Recalls Refinity Rotational Intravascular Ultrasound Catheters Due to Kinking

    Volcano Corporation is recalling 718 Refinity Rotational Intravascular Ultrasound Catheters because high complaint rates indicate kinking near the proximal shaft, which could disrupt clinical workflow or cause loss of imaging.

    Product
    Refinity Rotational Intravascular Ultrasound (IVUS) Catheter; Product number: 400-0200.289; Catalog number 89800. Cardiovascular: The REFINITY (or REFINITY ST) Rotational IVUS Catheter (REFINITY or REFINITY ST) is intended for the intravascular ultrasound examination of…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1771-2017·2017-04-19

    Cardiovascular Systems Recalls ViperWire Advance Peripheral Guide Wire Due to Sizing Error

    Cardiovascular Systems Inc. is recalling one lot of ViperWire Advance Peripheral Guide Wires because they may contain the wrong size product.

    Product
    ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide. The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radiopaque distal spring tip. The guide wire allows for proper positioning of the…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1792-2017·2017-04-19

    Windstone Medical Recalls Lasik Trays Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 260 Lasik Tray kits because the sterile packaging of the included Medtronic Curity Eye Pad may be compromised.

    Product
    Lasik Tray, part number DDS1045-2 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1754-2017·2017-04-19

    Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.

    Product
    MEDTECH ROSA Brain 3.0 The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device is…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1808-2017·2017-04-19

    2k Innovations Recalls Volt Resistance Frostie Heated Gloves for Unapproved Claims

    2k Innovations Inc. is recalling Volt Resistance Frostie Heated Gloves because FDA inspections found the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Frostie Heated Gloves (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1807-2017·2017-04-19

    2k Innovations Recalls Volt Heated Elbow Garments for Unapproved Claims

    2k Innovations is recalling 22,757 Volt Resistance Heated Elbow Garments because FDA inspections found the firm made unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Elbow Garment Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1810-2017·2017-04-19

    FDA Recalls Volt Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Slippers because FDA inspections found the product makes unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Slipper Black (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1812-2017·2017-04-19

    FDA Recalls Volt Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Slippers because the firm made unapproved therapy and medical claims on product information and its website.

    Product
    Volt Resistance Heated Slipper (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1806-2017·2017-04-19

    FDA Recalls Volt Heated Knee Wrap for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Heated Therapy Knee Wraps because FDA inspections found the product makes unapproved therapy and medical claims.

    Product
    Volt Resistance Heated Therapy Knee Wrap Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1797-2017·2017-04-19

    Windstone Medical Recalls PRK Trays Due to Sterile Packaging Concerns

    Windstone Medical Packaging is recalling 20 PRK kits because the sterile packaging of the included eye pads may be compromised.

    Product
    PRK Tray, part number DDS1044 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1818-2017·2017-04-19

    Keystone Dental Recalls PrimaConnex Straight Implants Due to Mislabeling

    Keystone Dental Inc. is recalling 59 PrimaConnex Straight Implants because they were incorrectly labeled as Tapered Implants.

    Product
    Keystone Dental Inc. PrimaConnex Straight Implant TC, WD Internal Connection 5.0 x 11.5mm. Catalog Number(s): 15636K
    Category
    Medical Device
    Distribution
    9 states
  • ModerateFDA (Devices)·Z-1813-2017·2017-04-19

    FDA Recalls Heated Slippers for Unapproved Medical Claims

    2k Innovations Inc. is recalling Volt Resistance Unisex Rechargeable Heated Slippers because FDA inspections found the company made unapproved therapy and medical claims.

    Product
    Volt Resistance Unisex Rechargeable Heated Slipper (All sizes) Deep penetrating heat garment and wraps
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1789-2017·2017-04-19

    Windstone ENT Pack Recall Due to Compromised Sterile Packaging

    Windstone Medical Packaging is recalling 16 ENT kits because the sterile packaging of the included Medtronic eye pads may be compromised.

    Product
    ENT Pack, part number AMS2727 Product packaged in a convenient manner for use in a general clinical procedure
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • LowFDA (Devices)·Z-1767-2017·2017-04-19

    Smiths Medical CADD Administration Set Recalled for Incorrect Filter Size Illustration

    Smiths Medical is recalling CADD Administration Sets because the illustration on the Instructions for Use incorrectly depicts the filter size as 2.0 microns instead of the actual 0.2 microns.

    Product
    CADD¿ Administration Set, 21-7339-24, Rx Only, Sterile EO.
    Category
    Medical Device
    Distribution
    43 states
  • SevereFDA (Devices)·Z-1739-2017·2017-04-12

    Recall of Sterile Eye Pads Due to Compromised Sterility Barrier

    Covidien LLC is recalling Curity Eye Pads because the sterile barrier was breached, potentially compromising sterility.

    Product
    Covidien Curity Eye Pad Item Code: 03201 The sterile eye pad is a device that consists of a pad made of various materials, such as gauze and cotton, intended for use as a bandage over the eye for protection or absorption of secretions. It is supplied sterile to allow for use…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1744-2017·2017-04-12

    Recall of Curity Sodium Chloride Dressings Due to Sterility Compromise

    Covidien LLC is recalling Curity Sodium Chloride Dressings because the sterile barrier is breached, compromising sterility. The recall affects lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Sodium Chloride Dressing , 6 x 6-3/4 (15.2 cm x 17.1 cm), Sterile Item Code: 3339 Curity Sodium Chloride Dressing is indicated for use on exudating and/or infected wounds
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1745-2017·2017-04-12

    Recall of Curity Saline Dressings Due to Compromised Sterility

    Covidien LLC is recalling Curity Saline Dressings because the sterile barrier was breached, compromising sterility. The recall covers lots with expiration dates from February 2017 through November 2019.

    Product
    Covidien Curity Saline Dressing 8' x 4 (20.3cm x10.2 cm), Sterile Item Code: 3606 Curity sodium chloride dressing is saturated in a 20% hypertonic saline solution. The dressing is designed to help promote biological cleansing within the wound and aid in the autolytic…
    Category
    Medical Device
    Distribution
    Distributed nationwide