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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20176–20200 of 40124

  • SevereFDA (Devices)·Z-1902-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Potential Screw Failure

    Siemens is recalling eight Artis X-ray systems because screws on the ceiling-mounted support may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen floor----Interventional Fluoroscopic X-Ray System Model Number: 10848353
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1900-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Potential Ceiling Mount Failure

    Siemens is recalling 73 Artis X-ray systems because ceiling-mounted support screws may loosen or snap, posing a risk of severe injury.

    Product
    Siemens Artis Q biplane---Interventional Fluoroscopic X-Ray System Model Number: 10848282
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1908-2019·2019-07-10

    Baxter Recalls Revaclear 300 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 300 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 300 Dialyzer, Product Code 114745L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-1903-2019·2019-07-10

    Siemens Artis X-Ray Systems Recalled for Ceiling Mount Screw Failure

    Siemens is recalling 15 Artis X-ray systems because ceiling mount screws may loosen or snap, posing a risk of severe injury to patients and staff.

    Product
    Siemens Artis Q.zen ceiling-Interventional Fluoroscopic X-Ray System Model Number: 10848354
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1935-2019·2019-07-10

    Ortho-Clinical VITROS 250 Chemistry System Recalled for CK Result Drift

    Ortho-Clinical Diagnostics is recalling 2,411 refurbished VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250 Chemistry System Refurbished, Product Code 6801759, (UDI # 10758750001330) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1909-2019·2019-07-10

    Baxter Recalls Revaclear 400 Dialyzers Due to Potential Fiber Rupture

    Baxter Healthcare is recalling Revaclear 400 dialyzers because ruptured fibers may cause blood leaks during hemodialysis treatment.

    Product
    REVACLEAR 400 Dialyzer, Product Code 114746L Revaclear 300 and Revaclear 400 dialyzers are indicated for treatment of chronic and acute renal failure by hemodialysis.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1931-2019·2019-07-10

    ZOLL AED PRO Defibrillators Recalled for Potential Energy Delivery Failure

    ZOLL Medical Corporation is recalling 1,969 AED PRO units because they may fail to deliver energy to patients during cardiac arrest.

    Product
    ZOLL AED PRO Automated External Defibrillator Product Usage: The AED PRO unit is intended to defibrillate victims of ventricular fibrillation or pulseless ventricular tachycardia, for ECG monitoring, and for CPR monitoring of patients. The CPR monitoring function provides a…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1930-2019·2019-07-10

    RaySearch Recalls Radiation Therapy Planning Software Due to Dose Calculation Errors

    RaySearch Laboratories AB is recalling RayStation and RayPlan software versions because electron Monte Carlo dose calculations may be incorrect when using a very large number of histories.

    Product
    RayStation 3.5, RayStation 4.0, RayStation 4.5, RayStation 4.7, RayStation 5, RayStation 6, RayPlan 1 (RayStation 4.9) and RayPlan 2 (RayStation 6) . Intended Use: software system designed for treatment planning and analysis of radiation therapy
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1911-2019·2019-07-10

    GE Healthcare Recalls Centricity PACS Foundation Software

    GE Healthcare is recalling Centricity PACS Foundation software because it may allow users to view incorrect patient images from external archives.

    Product
    Centricity PACS Foundation Centricity PACS software product is intended for the storage, reading, diagnostic review, analysis, annotation, distribution, printing, editing, and processing of digital images and data acquired from diagnostic imaging devices.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1936-2019·2019-07-10

    Ortho-Clinical VITROS 350 Chemistry System Recalled for CK Drift

    Ortho-Clinical Diagnostics is recalling VITROS 350 Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 350 Chemistry System, Product Code 6802153, (UDI # 10758750002054) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1910-2019·2019-07-10

    GE Healthcare Recalls Centricity Universal Viewer 6.0 Software

    GE Healthcare is recalling Centricity Universal Viewer 6.0 software due to a risk of displaying incorrect patient images from archives.

    Product
    Centricity Universal Viewer 6.0 Is a device that displays medical images and data from various imaging sources, and from other healthcare information sources.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1933-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250 Chemistry System for CK Drift

    Ortho-Clinical Diagnostics is recalling 5,020 VITROS 250 Chemistry Systems due to potential negative drift in Creatine Kinase results.

    Product
    VITROS 250 Chemistry System, Product Code 8132086, (UDI # 10758750004409) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1929-2019·2019-07-10

    Philips Recalls Vereos PET/CT Systems Due to Cover Misalignment

    Philips Medical Systems is recalling 70 Vereos PET/CT systems because misaligned covers may create gaps or protrude into the imaging bore.

    Product
    Vereos PET/CT, Model No. 882446 Product Usage: Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical cross-sections by computer reconstruction of X-ray transmission data. The PET subsystem images the distribution of…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1913-2019·2019-07-10

    Siemens ADVIA Chemistry Creatine Kinase Reagent Recalled for Absorbance Trend

    Siemens Healthcare Diagnostics is recalling ADVIA Chemistry Creatine Kinase (CK_L) reagent due to a steady upward trend in blank absorbance.

    Product
    ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 - Product Usage: The ADVIA¿ Chemistry Creatine Kinase (CK_L) assay is for in vitro diagnostic use in the quantitative determination of creatine kinase activity in human plasma…
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-1915-2019·2019-07-10

    Siemens SOMATOM go.Up CT Scanner Recalled for Performance Issues

    Siemens Medical Solutions is recalling nine SOMATOM go.Up CT scanners due to sporadic performance problems that may interrupt scanning workflows and delay patient diagnosis.

    Product
    SOMATOM go.Up (Model #11061610) with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1919-2019·2019-07-10

    Siemens SOMATOM go.Up CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Up CT systems due to sporadic performance problems that may cause diagnostic delays or patient rescans.

    Product
    SOMATOM go.Up, Model No. 11061628 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1934-2019·2019-07-10

    Ortho-Clinical Diagnostics Recalls VITROS 250AT Chemistry System

    Ortho-Clinical Diagnostics is recalling 57 VITROS 250AT Chemistry Systems due to potential negative drift in Creatine Kinase (CK) test results.

    Product
    VITROS 250AT Chemistry System, Product Code 1758143, (UDI # 10758750000036) Product Usage: Performs discrete clinical tests on serum, urine, and cerebral spinal fluid specimens. Methodologies include colorimetric (CM), potentiometric (PM), rate (RT), and immuno-rate (IR)…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1926-2019·2019-07-10

    Infinium Medical Recalls CLEO and Tranquility VS Patient Monitors

    Infinium Medical is recalling 95 CLEO and Tranquility VS patient monitors because their FDA clearance did not include the temperature monitor accessory option.

    Product
    CLEO Patient Monitor /Tranquility VS Patient Monitor
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1916-2019·2019-07-10

    Siemens SOMATOM go.Now CT Scanner Recall for Workflow Interruptions

    Siemens Medical Solutions is recalling 53 SOMATOM go.Now CT scanners due to potential sporadic performance problems that may cause scanning workflow interruptions and delays in diagnosis.

    Product
    SOMATOM go.Now (Model #11061620), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1920-2019·2019-07-10

    Siemens SOMATOM go.Now CT Systems Recalled for Performance Issues

    Siemens is recalling 69 SOMATOM go.Now CT systems due to potential performance problems that may cause diagnostic delays or the need for patient rescans.

    Product
    SOMATOM go.Now, Model No. 11061618 with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1946-2019·2019-07-10

    Zimmer Biomet Recalls DVR Crosslock ePAK Screw Drivers Due to Packaging Seal Risk

    Zimmer Biomet is recalling 3,022 DVR Crosslock ePAK Screw Drivers because sterile packaging seals may be weak, potentially compromising sterility.

    Product
    DVR Crosslock ePAK Screw Driver, Model Number 212000002 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1917-2019·2019-07-10

    Siemens SOMATOM go.All CT Systems Recalled for Performance Issues

    Siemens is recalling 24 SOMATOM go.All CT systems due to sporadic performance problems that may interrupt scanning workflows and delay diagnoses.

    Product
    SOMATOM go.All (Model #11061630), with syngo.CT software versions VA20A, VA20A_SP0, VA20_SP1. Product Usage: This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-1948-2019·2019-07-10

    Zimmer Biomet Recalls K-Wire Trochar Tips Due to Packaging Seal Issues

    Zimmer Biomet is recalling K-Wire Trochar Tips because the sterile packaging may have weak seals, potentially compromising the device's sterility.

    Product
    K-Wire Trochar Tip, Model Number 212000008 Product Usage: These DVR Express Disposable Instruments are used to facilitate implantation of orthopedic medical devices in trauma.
    Category
    Medical Device
    Distribution
    Distributed nationwide