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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18276–18300 of 27647

  • HighFDA (Devices)·Z-1597-2018·2018-05-09

    Siemens Biograph Horizon PET/CT Scanner Software Recall for Image Errors

    Siemens Medical Solutions is recalling 42 Biograph Horizon PET/CT scanners due to a software error that causes incorrect image reconstruction.

    Product
    Biograph Horizon - PET/CT, PETsyngo VJ20A Software Nuclear medicine/ xray diagnostic scanner.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1532-2018·2018-05-02

    BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Issues

    Becton Dickinson is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Push Button Blood Collection Set 0.8 x 19 mm x 305 mm 21G x ¿ x 12 Catalog 367344
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1477-2018·2018-05-02

    Ion Beam Applications Recalls Proteus Proton Beam Therapy Systems

    Ion Beam Applications is recalling five Proteus proton beam therapy systems because a software error may cause under-irradiation or additional X-ray exposure.

    Product
    Proteus 235, ProteusPLUS or Proteus ONE produces and delivers a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation.
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-1531-2018·2018-05-02

    BD Vacutainer Push Button Blood Collection Set Recalled for Sterility Failure

    Becton Dickinson & Company is recalling BD Vacutainer Push Button Blood Collection Sets because they do not meet the labeled sterility assurance level.

    Product
    BD Vacutainer¿ Push Button Blood Collection Set 0.6 x 19 mm x 305 mm 23G x ¿ x 12 (Catalog no 367342)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1505-2018·2018-05-02

    Stryker T4 Zipper Toga sterile garments recalled for layer separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga (S/M); Catalog Number: 0400-810-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1471-2018·2018-05-02

    Zimmer Biomet Recalls Pressure Sentinel Guide Wires Due to Sterile Seal Failure

    Zimmer Biomet is recalling 19,483 Pressure Sentinel Intramedullary Reaming System Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Pressure Sentinel Intramedullary Reaming System Guide Wire Bullet Tip 2.4 mm Diameter; Item Number: 00-2228-024-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1472-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Guide Wires Due to Sterile Seal Failure

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 100 cm Length; Diameter; Item Number: 47-2490-097-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1487-2018·2018-05-02

    Integra LifeSciences Recalls TCC-EZ Total Contact Cast System

    Integra LifeSciences is recalling 250 units of the TCC-EZ Total Contact Cast System because a quarantined lot may produce excessive heat.

    Product
    TCC-EZ, Total Contact Cast System, Model No. TCC2-4051
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1523-2018·2018-05-02

    Sofradim Versatex Monofilament Mesh Recalled for Hernia Recurrence Reports

    Sofradim Production is recalling Versatex Monofilament Mesh due to patient reports of abdominal hernia recurrence following repair. The firm has updated instructions to warn surgeons about risks in specific procedures.

    Product
    Versatex Monofilament Mesh 50 x 50cm, Product No. VTX5050M The device is made out of a macroporous three-dimensional monofilament polyester textile. Its intended use is for the repair of abdominal wall hernias or other fascial deficiencies that require the addition of a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1507-2018·2018-05-02

    Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T5 Zipper Toga with Peel-Away Face Shield, (L/XL); Catalog number: 0400-820-100 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1500-2018·2018-05-02

    Stryker T4 Pullover Toga Recalled for Potential Material Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, (S/M); Catalog Number: 0400-710-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1510-2018·2018-05-02

    Stryker T5 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T5 Zipper Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T5 Zipper Toga with Peel-Away Face Shield, (XL/T); Catalog number: 0400-850-100 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1476-2018·2018-05-02

    Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1468-2018·2018-05-02

    Zimmer Biomet Recalls Natural Nail System Tear Drop Guide Wires

    Zimmer Biomet is recalling 19,483 Natural Nail System Tear Drop Guide Wires due to a potential failure of the sterile packaging seal.

    Product
    Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1528-2018·2018-05-02

    EEA Hemorrhoid Stapler Recalled for Potential Welding Defect

    FDA is recalling EEA Hemorrhoid and Prolapse Stapler Sets due to a potential welding defect that could cause bleeding or anastomotic leak.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 4.8MM, Product Number HEM3348, GTIN Number 1 - 10884521047563, GTIN Number 2 - 20884521047560 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1465-2018·2018-05-02

    Zimmer Biomet Recalls Humeral Guide Wires Due to Packaging Seal Failure

    Zimmer Biomet is recalling 19,483 M/DN Intramedullary Fixation Humeral Guide Wires because the sterile packaging seal may fail, potentially compromising sterility.

    Product
    M/DN Intramedullary Fixation Humeral Guide Wire - Smooth 2.4 mm Diameter 70 cm Length Single Use Only; Item Number: 00-2255-025-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1513-2018·2018-05-02

    BioFire FilmArray BCID Panel Recalled for False Positive Proteus Results

    BioFire Diagnostics is recalling the FilmArray BCID Panel because it may produce false positive Proteus results when used with specific BD BACTEC blood culture bottles.

    Product
    FilmArray BCID Panel (Blood Culture Identification Panel), Catalog numbers RFIT-ASY-0126 (30 test kit) and RFIT-ASY-0127 (6 test kit), when used with all lots of BD BACTEC Blood Culture Bottles, Catalog numbers 442020, 442021, 442023, 442192, 442265, 442194, 442022, 442193…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1514-2018·2018-05-02

    Synthes Stem Extractor Recalled Due to Potential Screw Breakage

    Synthes, Inc. is recalling 31 Stem Extractor f/Guide Bar units because the connection screw may break during use.

    Product
    Stem Extractor f/Guide Bar, Part number 03.401.072. Instrumentation for extraction and revision of Epoca shoulder implants.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1509-2018·2018-05-02

    Stryker T4 Zipper Toga Recall Due to Material Separation Risk

    Stryker is recalling T4 Zipper Toga sterile garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, X-Large; Catalog number: 0400-850-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1527-2018·2018-05-02

    Recall of EEA Hemorrhoid and Prolapse Stapler Sets Due to Welding Defect

    Covidien LLC is recalling EEA Hemorrhoid and Prolapse Stapler Sets because a defective staple guide may cause bleeding or anastomotic leak during surgery.

    Product
    EEA" Hemorrhoid and Prolapse Stapler Set with DST Series" Technology 3.5MM, Product Number HEM3335, GTIN Number 1 - 10884521047518, GTIN Number 2 - 20884521047515 Product Usage: The EEA Hemorrhoid and prolapse stapler set with DST Series Technology (instrument) is designed…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1506-2018·2018-05-02

    Stryker T4 Zipper Toga Sterile Garment Recall for Layer Separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, creating a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, (L/XL); Catalog Number: 0400-820-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1508-2018·2018-05-02

    Stryker T4 Zipper Toga Sterile Garments Recalled for Layer Separation

    Stryker is recalling T4 Zipper Toga sterile personal protection garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Zipper Toga, Regular; Catalog number: 0400-830-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1470-2018·2018-05-02

    Zimmer Biomet Recalls ZMS Intramedullary Fixation Smooth Guide Wires

    Zimmer Biomet is recalling ZMS Intramedullary Fixation Smooth Guide Wires due to potential failure of the sterile packaging seal.

    Product
    ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1480-2018·2018-05-02

    Life Technologies Recalls Oncomine Dx Target Test Due to False Negative Risk

    Life Technologies is recalling 30 units of the Oncomine Dx Target Test because a lower RNA concentration could cause false negative results for ROS1 fusion, potentially affecting patient treatment.

    Product
    Oncomine Dx Target Test, (Model No. A32451), Oncomine Dx Target RNA/DNA Panel (Model No. A32441). A qualitative In Vitro Diagnostic test.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-1501-2018·2018-05-02

    Stryker T4 Pullover Toga Recalled for Potential Material Separation

    Stryker is recalling T4 Pullover Toga sterile garments because material layers may separate, posing a risk of exposure to contaminants.

    Product
    T4 Pullover Toga, L/XL; Catalog Number: 0400-720-000 Sterile personal protection garment
    Category
    Medical Device
    Distribution
    Distributed nationwide