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

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12551–12575 of 13802

  • 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-0321-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss

    Boston Scientific is recalling Hurricane RX dilation balloons used in endoscopic biliary procedures due to pinhole defects causing pressure loss that may prolong treatment.

    Product
    HURRICANE RX DILATION BALLOON 4MM 4CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545900
    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-0329-2022·2021-12-08

    GE Centricity Medical Imaging Software May Display Incomplete Patient Studies

    GE Healthcare recalled versions of Centricity Universal Viewer Zero Footprint Client software due to a potential defect that could display incomplete patient imaging studies. No injuries have been reported.

    Product
    GE Centricity Universal Viewer Zero Footprint Client
    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-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-0314-2022·2021-12-08

    Orthopedic Implant Head Package Lid May Debond From Sealed Package

    Howmedica Osteonics Corp. is recalling specific lots of the 28MM -4 LFIT V40 HEAD due to potential debonding of the outer Tyvek lid from the sealed package.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-122
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0311-2022·2021-12-08

    Cardiac Assist Procedure Kit Recalled for Incorrect Expiration Date Label

    Cardiac Assist, Inc. is recalling 7 units of the SHIP KIT cardiopulmonary bypass procedure kit due to an incorrect expiration date on the side label. The side label shows May 1, 2021, while the correct expiration date is May 1, 2022.

    Product
    SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable
    Category
    Medical Device
    Distribution
    4 states
  • ModerateFDA (Devices)·Z-0310-2022·2021-12-08

    Total Thyroxine ELISA Test Kits Recalled for Failed Quality Controls

    DRG International is recalling Total Thyroxine (T4) ELISA test kits due to failed quality controls affecting 314 units across multiple countries. The defective controls may delay diagnosis and waste patient samples.

    Product
    Total Thyroxine (T4) ELISA; REF EIA-1781
    Category
    Medical Device
    Distribution
    3 states
  • ModerateFDA (Devices)·Z-0313-2022·2021-12-08

    Orthopedic implant hip component recalled in Puerto Rico

    Howmedica Osteonics Corp. has recalled the 28MM -4 LFIT V40 HEAD orthopedic implant component (Catalog Number 6260-9-028) distributed to Puerto Rico. Lot numbers 86953401 and 86953503 are affected.

    Product
    28MM -4 LFIT V40 HEAD, Catalog Number 6260-9-028
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0319-2022·2021-12-08

    NUVASIVE PRECICE Limb Lengthening System: Updated Instructions Clarify Patient Selection

    NuVasive is updating instructions for the PRECICE limb lengthening implant system to clarify it is for patients 18 years or older weighing 50 lbs or more, with no more than two devices implanted at a time.

    Product
    NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description: CPA1-000 PA0382-001 End Cap CPA2-000 PA1051-000 PACKAGED END CAP, 8.5/ 10.7MM, +0MM CPA2-005 PA1051-005 PACKAGED END CAP, 8.5/ 10.7MM, +5MM CPA2-010 PA1
    Category
    Medical Device
    Distribution
    46 states
  • LowFDA (Devices)·Z-0316-2022·2021-12-08

    INBONE Total Ankle System Recalled Due to Package Labeling Mismatch

    Wright Medical Technology is recalling the INBONE Total Ankle System because package contents do not match the package labeling on affected units distributed in Michigan and Pennsylvania.

    Product
    INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS
    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-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-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-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-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-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-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-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-0269-2022·2021-12-01

    FDA Recalls Western Oxytote DTE Digital VIPR System Due to Battery Rupture Risk

    Western/Scott Fetzer Company is recalling 40 units of the Oxytote DTE Digital VIPR System due to battery rupture risk. The device may emit fumes and smoke when the battery ruptures and plastic shroud breaks apart.

    Product
    Western Oxytote DTE Digital VIPR System (with D-size cylinder) Model: MNDS-602
    Category
    Medical Device
    Distribution
    4 states
  • 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-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-0276-2022·2021-12-01

    Diagnostic thromboplastin reagent recalled due to performance issues

    Instrumentation Laboratory is recalling HemosIL ReadiPlasTin diagnostic reagent kits due to performance issues including imprecision and out-of-range quality controls that could result in inaccurate test results.

    Product
    HemosIL ReadiPlasTin (20 mL), Part number 0020301400. An in vitro diagnostic thromboplastin reagent.
    Category
    Medical Device
    Distribution
    Distributed nationwide