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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18201–18225 of 27534

  • HighFDA (Devices)·Z-1587-2018·2018-05-09

    Siemens Atellica Solution and Sample Handler Prime Recalled for Reporting Errors

    Siemens Healthcare Diagnostics is recalling Atellica Solution and Sample Handler Prime systems because reporting and conversion factors may not apply to all connected analyzers.

    Product
    Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1448-2018·2018-05-09

    Siemens SOMATOM Perspective 16 CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Perspective 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Perspective 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1452-2018·2018-05-09

    Siemens SOMATOM Emotion CT Scanner Recalled for Incorrect Dose Calculations

    Siemens is recalling 1,301 SOMATOM Emotion CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

    Product
    SOMATOM Emotion (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1453-2018·2018-05-09

    Siemens SOMATOM Sensation 10 CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Sensation 10 CT scanners due to a software error that may cause unnecessary radiation exposure during head scans.

    Product
    SOMATOM Sensation 10 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1595-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker C02 Cartridges Due to Sterility Concerns

    Cook Inc. is recalling 38,542 StoneBreaker C02 Cartridges because the interior may not be sterilized to the appropriate level when reprocessed.

    Product
    StoneBreaker C02 Cartridge, Catalog number: SBC-10; GPN: G52603; UDI: (01)10827002526034
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1593-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Probe Caps Due to Sterility Concerns

    Cook Inc. is recalling 370 StoneBreaker Probe Caps because the interior may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Probe Cap, Catalog number:SBA-PC; GPN: G52601; UDI:(01)00827002526013
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1591-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Exhaust Caps Due to Sterility Concerns

    Cook Inc. is recalling 629 StoneBreaker Exhaust Caps because the interior may not be sterilized to the appropriate level when following reprocessing instructions.

    Product
    StoneBreaker Exhaust Cap, Catalog number: SBA-EC; GPN: G52599; UDI: (01)00827002525993
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1457-2018·2018-05-09

    Siemens SOMATOM Sensation Open CT Scanner Recall for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation Open CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially leading to unnecessary exposure.

    Product
    SOMATOM Sensation Open Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1446-2018·2018-05-09

    Siemens SOMATOM Emotion 16 CT Scanner Recalled for Dose Calculation Error

    Siemens Medical Solutions is recalling 1,301 SOMATOM Emotion 16 CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1588-2018·2018-05-09

    Siemens Atellica IM 1600 Analyzer Recalled for Reporting Factor Errors

    Siemens Healthcare Diagnostics is recalling Atellica IM 1600 Analyzer systems because reporting and conversion factors may not apply to all connected analyzers.

    Product
    Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1459-2018·2018-05-09

    Siemens SOMATOM Emotion Duo CT Scanner Recalled for Radiation Dose Errors

    Siemens is recalling SOMATOM Emotion Duo CT scanners because a software algorithm may calculate incorrect radiation doses for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Emotion Duo (2003) Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1454-2018·2018-05-09

    Siemens SOMATOM Sensation 16 CT Scanner Recalled for Dose Calculation Errors

    Siemens is recalling 1,301 SOMATOM Sensation 16 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

    Product
    SOMATOM Sensation 16 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1449-2018·2018-05-09

    Siemens SOMATOM Scope CT Scanner Recalled for Incorrect Radiation Dose Calculations

    Siemens Medical Solutions is recalling SOMATOM Scope CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially leading to unnecessary radiation exposure.

    Product
    SOMATOM Scope Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1458-2018·2018-05-09

    Siemens SOMATOM Sensation 40 CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation 40 CT scanners because the CARE Dose4D algorithm may incorrectly calculate tube current for head scans, potentially causing unnecessary radiation exposure.

    Product
    SOMATOM Sensation 40 Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1590-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Pneumatic Lithotripter Due to Sterility Concerns

    Cook Inc. is recalling 751 units of the StoneBreaker Pneumatic Lithotripter because the device may not be properly sterilized during reprocessing.

    Product
    StoneBreaker Pneumatic Lithotripter, Catalog number: SBL-KIT1; GPN: G52604 UDI:(01)00827002526044
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1582-2018·2018-05-09

    Radiometer AQURE Software Recalled for Potential Patient Data Mix-Up

    Radiometer Medical ApS is recalling AQURE software versions 2.3.0 and 2.3.1 due to a potential problem that may result in patient mix-up.

    Product
    AQURE, Software version 2.3.0 and 2.3.1 Product Usage: The AQURE system is intended to let allow the management of analytical devices and operator profiles. The user can associate patient data with test data. The system shows test results. The system receives data from…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1596-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Single Use Probes for Sterility Concerns

    Cook Inc. is recalling 12,556 StoneBreaker Single Use Probes because the interior may not be properly sterilized. The recall covers units distributed in the US and 70 other countries.

    Product
    StoneBreaker Single Use Probe, Catalog numbers: SBP-010500; SBP-010605; SBP-016500; SBP-016605; SBP-020425 GPN : G52607; G52605; G52606; G52609; G52608
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1537-2018·2018-05-09

    Zimmer Biomet Recalls Modular Hip Head Components Due to Sizing Errors

    Zimmer Biomet is recalling 30 modular hip head components because two lots of different sizes were potentially commingled. This error could lead to the use of an incorrect sized head, causing surgery delays or dislocation.

    Product
    Modular Head Component, Biomet Hip System; Item No. 163669, Hip Joint, metal/polymer semi-constrained cemented prosthesis The device is used in treatment of patients who need total hip arthroplasty, and consists of modular components and corresponding instruments.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1455-2018·2018-05-09

    Siemens SOMATOM Sensation Cardiac CT Scanner Recalled for Dose Calculation Error

    Siemens is recalling 1,301 SOMATOM Sensation Cardiac CT scanners because a software algorithm may incorrectly calculate radiation dose for head scans, potentially exposing patients to unnecessary radiation.

    Product
    SOMATOM Sensation Cardiac Intended to produce cross-sections images of the body by computer reconstruction of x-ray transmission data.
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-1594-2018·2018-05-09

    Cook Inc. Recalls StoneBreaker Sterilization Caps Due to Sterility Concerns

    Cook Inc. is recalling 470 StoneBreaker Sterilization Caps because the interior may not reach the required Sterility Assurance Level during reprocessing.

    Product
    StoneBreaker Sterilization Cap, Catalog number: SBA-SC; GPN: G52602; UDI: (01)00827002526020
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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