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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16651–16675 of 27505

  • SevereFDA (Devices)·Z-0300-2019·2018-11-07

    Siemens Ysio MAX Radiographic Systems Recalled for Cable Failure Risk

    Siemens is recalling 31 Ysio MAX radiographic systems because steel cables in the lifting column may rupture, causing the arm to drop unexpectedly.

    Product
    Ysio MAX (model number 10762470) with Tube stand 3D V (model number 7042018 or 7042034), radiographic systems used in radiographic and tomographic exposures of the whole body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0298-2019·2018-11-07

    Siemens AXIOM Multix MT Patient Table Recalled for Cable Failure Risk

    Siemens is recalling 11 AXIOM Multix MT patient tables because steel cables may rupture, causing the arm to drop unexpectedly during patient positioning.

    Product
    AXIOM Multix MT (model number 8395415 or 8395399 or 8395381), a patient table used in conjunction with the Siemens Multix PRO- and TOP Systems radiographic exposures of the entire body.
    Category
    Medical Device
    Distribution
    38 states
  • SevereFDA (Devices)·Z-0289-2019·2018-11-07

    Stryker Recalls Hoffman LRF Hexapod Struts Due to Pin Displacement Risk

    Stryker GmbH is recalling 832 Hoffman LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 105mm-139mm, Model Number 4935-0-020. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0288-2019·2018-11-07

    Stryker Recalls Hoffmann LRF Hexapod Struts Due to Pin Fit Defect

    Stryker GmbH is recalling 578 Hoffmann LRF Hexapod Struts because a manufacturing defect may cause the pin to displace, compromising the stability of the orthopedic frame.

    Product
    Hoffman LRF Hexapod Strut, Extra Short 89mm-109mm, Model Number 4935-0-010. Product Usage - The Hoffmann LRF System is indicated in pediatric patients and adults for the treatment and fixation of: Open and closed fractures Post-traumatic joint contracture which has resulted…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0286-2019·2018-11-07

    Zimmer Biomet Recalls OsteoGen Bone Growth Stimulators for Cleanliness Issues

    Zimmer Biomet is recalling 4,879 OsteoGen Implantable Bone Growth Stimulators because the company could not ensure product cleanliness parameters were consistently met.

    Product
    EBI Osteogen Implantable Bone Growth Stimulator The OsteoGen Implantable Bone Growth Stimulator is indicated in the treatment of long bone nonunions.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0367-2019·2018-11-07

    Baxter Recalls EXACTAMIX Empty EVA Bags Due to Potential Leaking

    Baxter Healthcare is recalling 281,350 units of EXACTAMIX Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 3000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2019·2018-11-07

    Roche Diagnostics Recalls URISYS 1100 Urine Analyzers Due to Detection Limits

    Roche Diagnostics is recalling 14,398 URISYS 1100 Urine Analyzers because limits of detection for certain parameters were higher than listed, potentially causing false negative results.

    Product
    Roche Diagnostics URISYS 1100 Urine Analyzer Part Number: 03617556001 Product Usage: The URISYS 1100 Urine Analyzer is a reflectance photometer designed to automatically read and evaluate the results of Chemstrip 5 OB, Chemstrip 7, Chemstrip 10 MD, and Chemstrip 10 UA urine…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0304-2019·2018-11-07

    Philips Brilliance 64 CT Scanner Software Recall for Misleading Reports

    Philips is recalling Brilliance 64 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Brilliance 64 (Model No. 728231), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0303-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners because software version 4.2.0 generates confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance Big Bore Oncology CT (Model No. 728243) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0363-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 158,163 units of Exactamix Empty EVA Bags because they may leak after being used for compounding.

    Product
    EXACTAMIX Empty EVA Bags - 250 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0310-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity Core 128 CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity Core 128 (Model No. 728323), Software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0365-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 136,800 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 1000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0366-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 456,071 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 2000 mL Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0364-2019·2018-11-07

    Baxter Recalls Exactamix Empty EVA Bags Due to Leak Risk

    Baxter Healthcare is recalling 110,134 units of Exactamix Empty EVA Bags because they may leak after being used for compounding sterile solutions.

    Product
    EXACTAMIX Empty EVA Bags - 500 mL - Product Usage: A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2019·2018-11-07

    Philips IQon Spectral CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling IQon Spectral CT scanners with specific software versions because the Calcium Score report provides confusing and potentially misleading plaque analysis data.

    Product
    IQon Spectral CT (Model No. 728332), Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0311-2019·2018-11-07

    Philips Brilliance iCT SP CT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling 626 Brilliance iCT SP CT scanners because specific software versions generate confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT SP (Model No. 728311, Software Version 4.7.0 or 4.7.2 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2019·2018-11-07

    Philips CT Scanner Software Recall for Misleading Calcium Score Reports

    Philips is recalling 145 CT scanners with software version 4.2.0 because the Calcium Score report may display confusing plaque analyses, potentially leading to patient mistreatment.

    Product
    Brilliance Big Bore Radiology CT (Model No. 728244) software version 4.2.0 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0313-2019·2018-11-07

    BD Max Instrument Recall for False Positive Candida Results

    Becton Dickinson is recalling 49 refurbished BD Max instruments due to a confirmed trend of false positive Candida glabrata results when Trichomonas vaginalis is present.

    Product
    BD Max Instrument, Catalog Number 441916 441927 (refurbished instrument) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids from multiple specimen types. The…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0305-2019·2018-11-07

    Philips Brilliance iCT Scanners Recalled for Misleading Calcium Score Reports

    Philips is recalling Brilliance iCT scanners because software errors create confusing calcium score reports that may lead to patient mistreatment.

    Product
    Brilliance iCT (Model No. 728306), Software Version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0302-2019·2018-11-07

    Philips Recalls Vereos PET/CT Software Due to Image Errors

    Philips Medical Systems is recalling 61 units of Vereos PET/CT software version 2.0.1 due to errors that may produce incorrect images or disrupt procedures.

    Product
    Vereos PET/CT, Software version 2.0.1. Model Number: 882446 Product Usage: The Philips Vereos PET/CT system is a diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem images anatomical…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0308-2019·2018-11-07

    Philips Ingenuity CT Software Recall for Misleading Calcium Score Reports

    Philips is recalling Ingenuity CT scanners with software version 4.1.6 because the Calcium Score report may display confusing information, potentially leading to patient mistreatment.

    Product
    Ingenuity CT (Model No. 728326), software version 4.1.6 Product Usage: Computed Tomography X-ray systems intended to produce cross-sectional Images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes. These devices may…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2019·2018-11-07

    BD Max Instrument Reader Spare Part Recalled for False Positive Results

    Becton Dickinson is recalling 23 BD Max Instrument Reader Spare Parts due to a confirmed trend of false positive Candida glabrata results.

    Product
    BD Max Instrument Reader Spare Part, Catalog Number 8090369/443364, 44336409 (Repaired Reader spare part) - Product Usage: The BD MAX System, used in conjunction with appropriate extraction kits and reagents, is capable of automated extraction and purification of nucleic acids…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0295-2019·2018-11-07

    Arthrex Recalls Li-ion Battery Housings for AR-400 DrillSaw Sports 400 System

    Arthrex, Inc. is recalling 335 Li-ion Battery Housings for the AR-400 DrillSaw Sports 400 System because they may not provide a complete seal, allowing for potential fluid ingress.

    Product
    Li-ion Battery Housing for AR-400 DrillSaw Sports 400 System Product Usage: The battery housing is used to house the battery that powers the AR-400 DrillSaw Sports 400 device.
    Category
    Medical Device
    Distribution
    Distributed nationwide