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 deaths or serious injuries are reported, 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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Minimum severity

Any3+ (High and above)4+ (High and above)5+ (High and above)

Clear filters

10576–10600 of 27470

  • HighFDA (Devices)·Z-0326-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling HURRICANE RX Dilation Balloons due to a pinhole defect that causes pressure loss during endoscopic procedures. The device may fail to maintain necessary pressure, potentially prolonging procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545950
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0317-2022·2021-12-08

    HALYARD STERLING ZERO Nitrile Exam Gloves Recall for Discoloration and Loss of Elasticity

    O&M Halyard is recalling HALYARD STERLING ZERO nitrile exam gloves in all sizes due to discoloration and loss of elasticity with aging, making the gloves difficult or impossible to don without tearing. Approximately 5.86 million gloves distributed worldwide are affected.

    Product
    HALYARD STERLING ZERO NITRILE POWDER-FREE EXAM GLOVES, Sizes XS, S, M, L, and XL
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0331-2022·2021-12-08

    Siemens Dimension Vista 500 software issue affects test accuracy

    Siemens is recalling 1,326 Dimension Vista 500 diagnostic devices worldwide due to incorrect default hemolysis, icterus, and lipemia indices that may affect test result accuracy.

    Product
    Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures such as pipetting, mixing, heating, and measuring spectral intensities to determine a variety of analytes in human body fluid SMN: 10284473 (US) and 10488224 (OUS)
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0320-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloons Recalled for Pressure Loss Defect

    Boston Scientific is recalling specific lots of Hurricane RX Dilation Balloons due to a pinhole defect that causes pressure loss, resulting in prolonged endoscopic procedures. Affected devices are used for dilating strictures in the bile duct.

    Product
    HURRICANE RX DILATION BALLOON 4MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545890
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0318-2022·2021-12-08

    Blood collection devices recalled due to premature needle retraction

    Magnolia Medical Technologies is recalling Steripath Gen2 Blood Collection Systems due to an uptick in complaints of premature needle retraction during blood collection.

    Product
    The Steripath Gen2 Blood Collection System Model Number/Description 2700-21-EN / Steripath Gen2 Blood Collection System - 21G, Wide Neck 2700-23-EN / Steripath Gen2 Blood Collection System - 23G, Wide Neck 27BD-21-EN / Steripath Gen2 Blood Collection System - 21G, Long Neck
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0312-2022·2021-12-08

    Blood Culture Identification Test Recalled Due to False Positive Risk

    BioFire Blood Culture Identification 2 (BCID2) diagnostic panels are being recalled due to increased risk of false positive Acinetobacter calcoaceticus-baumannii results caused by non-viable contamination in blood culture vials.

    Product
    BioFire Blood Culture Identification 2 (BCID2) Panel Part No: RFIT-ASY-0147 UDI: 00815381020338 Blood Culture Catalog No./Description: 442023/BD BACTEC Plus Aerobic medium in plastic vials 442021/BD BACTEC Lytic Anaerobic medium in plastic vials 442192//BD BACTEC Plus Aerobic me
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0323-2022·2021-12-08

    Boston Scientific HURRICANE RX Dilation Balloon Pressure Loss Recalled

    Boston Scientific is recalling HURRICANE RX Dilation Balloons across the US due to pinhole defects that cause pressure loss during endoscopic procedures. The defect may prolong procedures and affect patient safety.

    Product
    HURRICANE RX DILATION BALLOON 6MM 4CM- -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545920
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0309-2022·2021-12-08

    NuStat Trauma Pad XR Hemafiber Recalled for Elevated Endotoxin Levels

    Beeken Biomedical is recalling NuStat 8-by-12-inch Trauma Pad XR Hemafiber in a 5-pack because endotoxin levels exceeded allowable limits. The recall affects 15 units distributed in Missouri.

    Product
    NuStat 8" x12" Trauma Pad XR Hemafiber, 5-pack. For temporary control of internal organ space bleeding REF: XR-0812-5
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0280-2022·2021-12-01

    Philips CT Fluoroscopy Ceiling Mount Bracket Wear and Detachment Hazard

    Philips Continuous CT Fluoroscopy ceiling mounts may experience monitor bracket assembly wear that goes undetected, potentially causing the bracket to detach and fall on patients, operators, or bystanders during surgery.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 16 System Number: 882470 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0281-2022·2021-12-01

    Continuous CT Fluoroscopy Ceiling Mount Bracket Assembly Wear Recall

    Monitor bracket assemblies in Philips Continuous CT Fluoroscopy systems may experience significant wear and detach, potentially injuring patients, operators, or bystanders during surgical procedures.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini TF 64 System Number: 882471 Continuous CT (CCT) is a CT or PET/CT product option that enables physicians and radiologists to produce real-time CT images to facilitate image-guided surgery.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0267-2022·2021-12-01

    Roberts Digital VIPR System Battery Rupture Risk Recall

    Western/Scott Fetzer Company is recalling 11,341 Roberts Digital VIPR System units distributed to Connecticut, Maryland, Montana, and Ohio due to battery rupture risk that could cause the plastic shroud to break apart and emit fumes and smoke.

    Product
    Roberts Digital VIPR System (with E-size cylinder) Model: ROC-9840
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0287-2022·2021-12-01

    CT Scanner Software May Cause Workflow Interruptions and Diagnosis Delays

    Siemens SOMATOM Drive CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnosis and require additional patient scans. Approximately 75 units are affected nationwide.

    Product
    SOMATOM Drive with software syngo.CT VB20 Model #10431700
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0301-2022·2021-12-01

    Siemens Artis Q angiography systems may fail to deliver x-ray during procedures

    Siemens Artis Q angiography systems may fail to release x-ray when source-to-image distance lift and x-ray release are activated simultaneously, causing procedure delays.

    Product
    Artis Q ceiling with software VD12-angiography systems developed for single and biplane diagnostic imaging and interventional procedure Model Number: 10848281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0292-2022·2021-12-01

    Medtronic Endurant IIs stent graft recalled due to spindle detachment risk

    Medtronic recalls 419 Endurant IIs stent grafts due to risk of spindle detachment from the hypotube during deployment.

    Product
    Endurant IIs Stent Graft System REF/Description: ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF2814C103EE STENT GRAFT ESBF2814C103EE ENDUR IIS BIF ESBF281
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0285-2022·2021-12-01

    Siemens CT Scanner Software May Cause Diagnostic Workflow Delays

    Siemens SOMATOM Definition Edge CT scanners with syngo.CT VB20 software may experience workflow interruptions, causing diagnostic delays, need for repeat scans, and additional contrast media use. 298 units nationwide are affected.

    Product
    SOMATOM Definition Edge with software syngo.CT VB20 Model #10590000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0290-2022·2021-12-01

    Endurant Stent Graft System spindle detachment during deployment

    Medtronic recalls 2 Endurant Stent Graft System devices due to potential spindle detachment from the hypotube during surgical deployment. The mechanical failure could affect graft positioning.

    Product
    Endurant Stent Graft System REF/Description: ENTF2525C70EE STENT GRAFT ENTF2525C70EE ENDURANT TUBE
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0272-2022·2021-12-01

    Clinical Chemistry Analyzer Software Defects May Produce Inaccurate Results

    Abbott ARCHITECT clinical chemistry analyzers with software 9.41 and earlier contain defects affecting calibration, sample handling, and quality control that may produce inaccurate diagnostic results.

    Product
    ARCHITECT c4000 REF 02P24-01/2P24, 1P86, 1R24, and 1R25; ARCHITECT c8000 REF 01G06-11/1G06; ARCHITECT c16000 REF 03L77-01/3L77;
    Category
    Medical Device
    Distribution
    50 states
  • HighFDA (Devices)·Z-0239-2022·2021-12-01

    Medical imaging device missing required radiation safety labels

    Philips Healthcare is recalling DigitalDiagnost C90 medical imaging devices because some units lack required radiation warning labels and X-ray certification statements. Affected customers should contact Philips to have the missing labels applied.

    Product
    DigitalDiagnost C90
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0293-2022·2021-12-01

    Medtronic Wireless Recharger for InterStim Micro May Become Unresponsive

    Medtronic's wireless recharger for the InterStim Micro implantable neurostimulator may become unresponsive if charging procedures from the user guide are not followed. Approximately 10,081 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9220 included in the RS5200 Recharger Kit used by the InterStim Micro (Model 97810) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0242-2022·2021-12-01

    GE Healthcare CT Systems Display Incorrect Radiation Doses During Certain Exams

    GE Healthcare's Revolution CT systems may display accumulated radiation doses up to 100 times higher than the actual dose delivered during certain interventional imaging procedures. The displayed value is incorrect, but the actual dose patients receive is accurate.

    Product
    Computed Tomography Systems Revolution CT, Revolution CT ES, Revolution Apex, Revolution CT with Apex edition
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0306-2022·2021-12-01

    BD Nexiva IV Catheters Recalled Due to Non-Sterile Packaging Breach

    Becton Dickinson is recalling BD Nexiva IV catheter systems because of a packaging breach that renders them non-sterile. The recall affects 155,840 devices distributed nationwide.

    Product
    BD Nexiva, 20 GA 1.00 IN (1.1 X 25 mm), 3660 ml/hr. 61ml/min; Closed IV Catheter System- Dual port -61 mL/min (3660 mL/hr)-0.5mL, REF 383536; BD Q-Style Luer Access Split Septum BD Vialon Material; BD Instaflash Needle Technology; Rx Only, Sterile EO. BD Nexiva closed IV cat
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0289-2022·2021-12-01

    CT Scanner Software May Cause Workflow Delays and Patient Rescans

    Siemens SOMATOM Edge Plus CT scanners with syngo.CT VB20 software may experience workflow interruptions, potentially delaying diagnoses and requiring patient rescans. The issue affects 64 units nationwide.

    Product
    SOMATOM Edge Plus with software syngo.CT VB20 Model #10267000
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0291-2022·2021-12-01

    Medtronic Endurant II Stent Graft Systems Recalled Due to Potential Spindle Detachment

    Medtronic is recalling 511 Endurant II Stent Graft Systems because during deployment, the spindle may detach from the distal end of the spindle hypotube.

    Product
    Endurant II Stent Graft System REF/Description: ETBF2513C145EE STENT GRAFT ETBF2513C145EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166EE STENT GRAFT ETBF2820C166EE ENDUR II BIF ETBF2820C166
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0286-2022·2021-12-01

    CT Scanner Software Issue Causes Workflow Interruptions and Diagnostic Delays

    Siemens SOMATOM Definition Flash CT scanners with syngo.CT VB20 software may experience workflow interruptions that delay diagnoses and require additional rescans and contrast media. This recall affects 121 units distributed nationwide.

    Product
    SOMATOM Definition Flash with software syngo.CT VB20 Model #10430603
    Category
    Medical Device
    Distribution
    Distributed nationwide