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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12526–12550 of 13802

  • SevereFDA (Devices)·Z-0340-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Manufacturing Defect

    Covidien Llc is recalling 278 Puritan Bennett 980 Series Ventilators due to a manufacturing assembly error where a capacitor may have been installed incorrectly, potentially causing device inoperability during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980S1ENDICU
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0351-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Error Risk

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor that may cause the device to become inoperable during use. This recall affects units worldwide and in the US.

    Product
    Puritan Bennett 980 Series Ventilator, 980X2ESDIEC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0339-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Assembly Defect

    Covidien is recalling Puritan Bennett 980 Series Ventilators due to an assembly error in a capacitor. The defect may cause the ventilator to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A3ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0346-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recalled for Capacitor Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators (Model 980X1ENDIPC) due to incorrect capacitor assembly that may cause the device to malfunction during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0354-2022·2021-12-15

    SuperCore Biopsy Instruments Recalled for Component Detachment Risk

    Argon Medical Devices is recalling 79,910 SuperCore Biopsy Instruments due to housing and plunger components detaching from the semi-automatic devices. The devices were distributed worldwide and throughout the United States.

    Product
    SuperCore Biopsy Instrument: REF/Product Description: 701114090/SUPERCORE BIOPSY INSTR 14GA X 9CM; 701114150/SUPERCORE BIOPSY INSTR 14GA X 15CM; 701116090/SUPERCORE BIOPSY INSTR 16GA X 9CM; 701118060/SUPERCORE BIOPSY INSTR 18GA X 6CM; 701118090/SUPERCORE BIOPSY INSTR 18GA
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0356-2022·2021-12-15

    Philips BV Pulsera X-ray Systems Missing Required Temperature Documentation

    Philips has recalled BV Pulsera mobile X-ray systems due to missing temperature specifications in the instructions for use. The X-ray tank and image intensifier lack maximum surface temperature documentation, creating a burn hazard.

    Product
    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0355-2022·2021-12-15

    Philips BV Endura diagnostic X-ray system missing temperature specifications

    Philips BV Endura diagnostic X-ray systems lack specifications for maximum surface temperatures in their instructions, creating potential for burn injuries.

    Product
    BV Endura with Software Release 2.3- A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718075
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0357-2022·2021-12-15

    Diagnostic X-ray imaging system recalled for incomplete temperature specifications

    Philips Veradius Unity diagnostic X-ray systems lack required temperature specifications in instructions, creating burn risk. Affected systems should not be used until updated documentation is received.

    Product
    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0333-2022·2021-12-15

    Boston Scientific AUTOLITH TOUCH lithotripter power controls reversed in four languages

    Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter devices distributed to Massachusetts have reversed high and low power settings in Russian, Romanian, Slovak, and Czech language versions. Users selecting a power level may receive the opposite setting.

    Product
    Boston Scientific AUTOLITH TOUCH Bipolar Electrohydraulic Lithotripter, REF M005466800. The device is designed to be used with Northgate Technologies Inc. bipolar disposable EHL probes for the fragmentation of calculi.
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0345-2022·2021-12-15

    Puritan Bennett 980 Ventilators Recalled Due to Manufacturing Assembly Error

    Covidien is recalling Puritan Bennett 980 Series Ventilators (model 980X1ENAIQC) due to an incorrectly assembled capacitor that may cause the device to become inoperable. The recall involves 278 units distributed worldwide, including the US.

    Product
    Puritan Bennett 980 Series Ventilator,980X1ENAIQC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0332-2022·2021-12-15

    Covidien Sonicision Battery Charger Recalled Due to Electric Shock Risk

    Covidien is recalling Sonicision Battery Chargers (serial numbers MCSB006939 and MCSB006947) due to a risk of electric shock if used with a faulty or bypassed grounding circuit.

    Product
    Covidien Sonicision Battery Charger-intended to charge the Sonicision Reusable Battery Pack and to provide information on the battery charging progress and battery pack status Item Code: CBCA
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0334-2022·2021-12-15

    Orthodontic Software Documentation Recalled for Unapproved Labeling Changes

    Orchestrate Orthodontic Technologies recalls O3D ORCHESTRATE user documentation because the labeling was altered from its FDA-approved version. Approximately 127 copies were distributed to practitioners worldwide.

    Product
    O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0315-2022·2021-12-08

    INBONE Total Ankle System recalled for package-labeling mismatch

    Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.

    Product
    INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0324-2022·2021-12-08

    Boston Scientific Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon nationwide due to a pinhole defect causing loss of pressure or failure to maintain pressure during endoscopic procedures used to treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 2CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545930
    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-0308-2022·2021-12-08

    Abbott HeartMate Touch System App may fail due to Bluetooth interference issue

    The Abbott HeartMate Touch Communication System may experience temporary app failure when nearby Bluetooth devices attempt connections. Once properly connected, the system functions normally.

    Product
    Abbott HeartMate Touch Communication System, REF: HMT1100 (US), HMT1100-R (Rental US), HMT1150 (EU)
    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-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
  • 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-0325-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled Due to Pinhole Defect Causing Pressure Loss

    Boston Scientific is recalling certain lots of the Hurricane RX Dilation Balloon due to a pinhole defect that causes loss of pressure or prevents the balloon from gaining or maintaining pressure during use, potentially prolonging medical procedures.

    Product
    HURRICANE RX DILATION BALLOON 8MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545940
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • 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-0322-2022·2021-12-08

    Hurricane RX Dilation Balloon Recalled for Pressure Loss Defect

    Boston Scientific is recalling the Hurricane RX Dilation Balloon due to a pinhole defect causing pressure loss during endoscopic procedures. The defect may result in prolonged procedures and inability to effectively treat biliary strictures.

    Product
    HURRICANE RX DILATION BALLOON 6MM 2CM-for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN:M00545910
    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-0246-2022·2021-12-08

    UV-C Germicidal Wand Recalled for Excessive Ultraviolet-C Radiation

    MAX LUX CORP is recalling approximately 9900 handheld UV-C germicidal wands (Safe-T Lite) distributed nationwide due to excessive ultraviolet-C radiation emissions.

    Product
    The product is a handheld ultraviolet-C germicidal wand and contains two, narrow-diameter, tubular lamps with a peak emission wavelength in the 254 nm range with an intended use of disinfecting surfaces.
    Category
    Medical Device
    Distribution
    Distributed nationwide