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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12601–12625 of 13837

  • 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-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-0279-2022·2021-12-01

    PET/CT Imaging System Ceiling Mount May Detach Due to Bracket Wear

    Philips TruFlight Select PET/CT imaging systems have a Monitor Bracket Assembly that may detach from the ceiling mount due to undetected shaft wear, posing a risk of injury to patients, staff, and bystanders.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - TruFlight Select PET/CT System Number: 882438 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-0274-2022·2021-12-01

    Freelite Human Lambda Free Kit Recalled for Calibration Curve Inaccuracy

    The Binding Site Group recalled 2,254 Freelite Human Lambda Free Kits due to calibration curve issues that may produce higher-than-expected activity readings and affect measurement accuracy.

    Product
    Freelite Human Lambda Free Kit (for use on the SPAPLUS) REF LK018.S Freelite Human Lambda Free Kit (for use on the SPAPLUS) (x10) REF LK018.10S
    Category
    Medical Device
    Distribution
    13 states
  • 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-0294-2022·2021-12-01

    Medtronic Wireless Recharger for Activa RC May Become Unresponsive

    Medtronic wireless rechargers for the Activa RC neurostimulator may become unresponsive if charging instructions from the patient user guide are not precisely followed. Approximately 6,406 devices are affected nationwide.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS6200 Recharger Kit used by the Activa RC (Model 37612) implantable neurostimulator.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0307-2022·2021-12-01

    Ocean Water Seal Chest Drain Recalled for Inadequate Setup Instructions

    Atrium Medical is recalling 87,972 Ocean Water Seal Chest Drains due to inadequate setup instructions that may result in treatment delays and risk of patient harm.

    Product
    The Ocean Water Seal Chest Drain is a plastic, three bottle vacuum collection device. It consists of a collection chamber that holds shed mediastinal blood, a water seal chamber using a water seal that prevents air from entering into the pleural space and a suction control chambe
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0288-2022·2021-12-01

    Siemens SOMATOM Confidence CT Scanners Recalled for Software-Related Workflow Interruptions

    Siemens SOMATOM Confidence CT scanners may experience software-related workflow interruptions that could delay patient diagnosis. The recall affects 104 units nationwide; affected facilities should contact the manufacturer for remediation instructions.

    Product
    SOMATOM Confidence with software syngo.CT VB20 Model #10590100
    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-0268-2022·2021-12-01

    Western Digital VIPR Medical Device Recalled for Battery Rupture Risk

    Western/Scott Fetzer is recalling Digital VIPR devices (Model MNDR-600) due to battery rupture risk that could cause plastic shroud breakage and fume emission. The recall affects 4974 units distributed from May 2020 to August 2021.

    Product
    Western Oxytote DTE Digital VIPR (head only) Model: MNDR-600
    Category
    Medical Device
    Distribution
    4 states
  • 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-0270-2022·2021-12-01

    Western Oxytote VIPR System Battery Rupture Risk with Fume Emission

    Western/Scott Fetzer Company is recalling 40 units of the Western Oxytote DTE Digital VIPR System due to battery rupture risk that can break the plastic shroud and release fumes and smoke.

    Product
    Western Oxytote DTE Digital VIPR System (with E-size cylinder) Model: MNDS-603
    Category
    Medical Device
    Distribution
    4 states
  • HighFDA (Devices)·Z-0271-2022·2021-12-01

    Abbott ARCHITECT Analyzer Software Issues May Cause Inaccurate Test Results

    Abbott is recalling approximately 20,994 ARCHITECT i1000SR, i2000SR, and i2000 automated analyzers due to 12 software-related issues in version 9.41 and earlier that may produce inaccurate diagnostic test results.

    Product
    ARCHITECT i1000SR REF 01L86-01/1L86 and 1L87; ARCHITECT i2000SR REF 03M74-02/3M74; ARCHITECT i2000 REF 08C89-01/1G17 and 8C89
    Category
    Medical Device
    Distribution
    49 states
  • HighFDA (Devices)·Z-0238-2022·2021-12-01

    Philips Azurion System Recall for 3D Image Reconstruction Defect

    Philips Healthcare is recalling Azurion systems with software releases 2.1(L1) and 2.1(L2) due to a software defect that prevents proper reconstruction of 3D X-ray images when the detector is positioned outside required tolerance.

    Product
    Philips Azurion systems with software releases 2.1(L1) and 2.1(L2)
    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
    49 states
  • 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-0278-2022·2021-12-01

    Imaging device ceiling mount assembly may detach, posing injury risk

    A ceiling-mounted component on Philips CT imaging equipment may detach due to wear. This poses a risk of injury to patients, operators, or staff in operating rooms.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - Gemini GXL 16 Slice System Number: 882410 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-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-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-0277-2022·2021-12-01

    CT imaging system ceiling mount bracket shaft wear may cause equipment to fall

    A CT fluoroscopy imaging system ceiling mount's bracket shaft may wear excessively and go undetected, potentially causing the bracket to detach and fall, risking injury to patients, operators, or service personnel.

    Product
    Continuous CT Fluoroscopy DVI Ceiling Mount - CCT Arm DVI Option - CT Vision ACQSIM CT System Number: 728209 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-0295-2022·2021-12-01

    Medtronic Wireless Recharger Model WR9200 Becomes Unresponsive on Improper Use

    Medtronic is recalling the Wireless Recharger Model WR9200 used with RestoreUltra and RestoreSensor neurostimulator implants. The recharger becomes unresponsive if charging instructions from the user guide are not followed correctly.

    Product
    Medtronic Wireless Recharger Model WR9200 included in the RS7200 Recharger Kit used by the RestoreUltra (Model 37712), RestoreSensor (Model 37714), Restore Ultra SureScan MRI (Model 97712), and RestoreSensor SureScan MRI (Model 97714) implantable neurostimulators.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0283-2022·2021-12-01

    CT Scanner Software Issue May Interrupt Diagnostic Workflows and Delay Diagnoses

    Siemens SOMATOM Force CT scanners with software syngo.CT VB20 may experience workflow interruptions, causing diagnosis delays and requiring additional patient scans and contrast media. No illnesses or injuries have been reported.

    Product
    SOMATOM Force with software syngo.CT VB20 Model #10742326
    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
  • 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