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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10576–10600 of 27441

  • SevereFDA (Devices)·Z-0353-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Error

    Covidien LLC is recalling 278 Puritan Bennett 980 Series Ventilators due to a capacitor assembly error that may cause the device to become inoperable during use. Affected devices were distributed worldwide with specific serial numbers targeted.

    Product
    Puritan Bennett 980 Series Ventilator, 980X3JADIJJ
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0338-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator recalled for capacitor assembly error

    The Puritan Bennett 980 Series Ventilator is being recalled because a capacitor may be assembled incorrectly, which could cause the ventilator to stop working during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980A1ENNISB
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0350-2022·2021-12-15

    Puritan Bennett 980 Series Ventilator Recall Due to Assembly Defect

    Covidien is recalling 278 Puritan Bennett 980 Series Ventilators worldwide due to an assembly error where a capacitor was incorrectly installed, potentially causing the device to become inoperable during use.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1PLDIPC
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0348-2022·2021-12-15

    Puritan Bennett 980 Ventilator recalled for capacitor assembly defect

    The Puritan Bennett 980 Series Ventilator may become inoperable due to a manufacturing defect in the internal capacitor assembly. A total of 278 units worldwide have been affected.

    Product
    Puritan Bennett 980 Series Ventilator, 980X1ENNISB
    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
  • 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
  • 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-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…
    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-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-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-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-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-0327-2022·2021-12-08

    FDA Recalls Hurricane RX Dilation Balloons for Pressure Failure Risk

    Boston Scientific is recalling Hurricane RX Dilation Balloons nationwide due to pinhole defects that cause pressure loss or failure to maintain pressure during endoscopic procedures.

    Product
    HURRICANE RX DILATION BALLOON 10MM 4CM -for endoscopic dilatation of strictures of the biliary tree and the Sphincter of Oddi. UPN: M00545960
    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-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-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-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-0330-2022·2021-12-08

    Dimension Vista 1500 Diagnostic Device: Incorrect HIL Index Defaults

    Siemens is recalling 1,407 Dimension Vista 1500 diagnostic devices worldwide due to incorrect default Hemolysis, Icterus, and Lipemia (HIL) index values affecting five assays.

    Product
    Dimension Vista 1500 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: 10444801(US) and 10444802 (OUS)
    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
  • 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-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…
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0328-2022·2021-12-08

    Cholesterol test system recalled due to calibration failure

    RANDOX CHOL cholesterol test system is recalled due to a calibration defect that causes quality control results to be flagged as out of range. This could result in inaccurate cholesterol measurements in patient samples.

    Product
    RANDOX CHOL-cholesterol (total) test system intended to measure cholesterol in plasma and serum REF: CH200
    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…
    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
    1 state