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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12726–12750 of 13837

  • HighFDA (Devices)·Z-0181-2022·2021-11-03

    Siemens Advia Chemistry Urinary Protein Reagent Recall for Inaccurate Test Results

    Siemens is recalling Advia Chemistry Urinary/Cerebrospinal Fluid Protein reagent due to potential reagent carryover that may cause falsely depressed Hemoglobin A1c results, which could affect clinical decisions about patient treatment.

    Product
    Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0177-2022·2021-11-03

    Bivona Aire-Cuf Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical is recalling 7136 Bivona Aire-Cuf Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. The issue affects specific lot numbers with 325mm shaft length.

    Product
    Bivona Aire-Cuf Endotracheal Tube
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0169-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder devices labeled with incorrect expiration date

    W L Gore recalled 846 GORE CARDIOFORM Septal Occluder units labeled with a 3-year expiration instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0170-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates is recalling 187 units of GORE CARDIOFORM Septal Occluders because they are labeled with a 3-year expiration date instead of the correct 2-year expiration date. Using the device beyond its actual shelf life could compromise its safety and effectiveness.

    Product
    REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0164-2022·2021-11-03

    Gore CARDIOFORM Septal Occluder recalled for incorrect expiration date

    W.L. Gore & Associates is recalling 2,238 GORE CARDIOFORM SEPTAL OCCLUDER 30 mm devices labeled with a 3-year expiration date instead of the actual 2-year expiration date.

    Product
    REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0173-2022·2021-11-03

    Medtronic recalls C315-HIS Delivery Catheters due to functional defect

    Medtronic is recalling 591 units of C315-HIS Delivery Catheters due to reports that a lead cannot pass through the catheter. The catheters were distributed internationally to multiple countries, and healthcare providers should contact Medtronic for guidance.

    Product
    C315-HIS Delivery Catheter
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0175-2022·2021-11-03

    Cliquid MD Software Version 3.4 May Provide Incorrect Analytical Results

    AB SCIEX's Cliquid MD version 3.4 software may incorrectly calculate Internal Standard concentrations when users hide or leave the IS column empty in customized LC-MS/MS tests, potentially leading to incorrect analytical conclusions.

    Product
    Cliquid MD version 3.4 software used in conjunction with Analyst MD software on SCIEX Citrine & 4500MD series liquid chromatography-tandem mass spectrometry (LC-MS/MS) systems. Model No. 5088288
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0179-2022·2021-11-03

    BD Syringe Tip Cap Packaging Defect May Compromise Sterility

    Becton Dickinson & Company is recalling BD Syringe Tip Caps (Catalog Number 305822, Lot 1111347) due to holes in the packaging that may compromise sterility and container closure integrity.

    Product
    BD Syringe Tip Cap Bulk Sterile Convenience Pak-1000 units/shelf carton. Used to seal syringes and maintain container closure integrity throughout the shelf life of the BD WWD syringe. Catalog Number: 305822
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0171-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Label

    W L Gore & Associates is recalling 222 GORE Cardioform Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year expiration.

    Product
    REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • HighFDA (Devices)·Z-0178-2022·2021-11-03

    Bivona Uncuffed Endotracheal Tubes Recalled for Compromised Sterile Barrier

    Smiths Medical ASD Inc. is recalling 2,191 Bivona Uncuffed Wire Endotracheal Tubes due to inadequate pouch seals that compromise the sterile barrier. Affected devices have 325mm shaft lengths and were distributed nationwide and internationally.

    Product
    Bivona Uncuffed Wire Endotracheal Tubes,
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0176-2022·2021-11-03

    ASC PneumoLiner surgical device recalled due to manufacturing orientation defect

    Olympus recalls ASC PneumoLiner surgical devices due to incorrect orientation of the containment bag that deploys upside down. This increases the risk of trapping bowel tissue during gynecologic laparoscopic surgery.

    Product
    ASC PneumoLiner device, Part No. WA90500US (US market only) The Pneumoliner device is intended for use as a multiple instrument port and tissue containment system during minimally invasive gynecologic laparoscopic surgery to enable the isolation and containment of tissue, cons
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0180-2022·2021-11-03

    Siemens Atellica CH Protein Reagent Recalled for Carryover Affecting Test Results

    Siemens Healthcare is recalling Atellica CH Urinary/Cerebrospinal Fluid Protein reagent due to potential carryover causing falsely depressed Hemoglobin A1c results that may affect clinical decision-making.

    Product
    Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0001-2022·2021-11-03

    RAPTAR Laser Range Finders Recalled for Field Modification Safety Risk

    Potomac River Group recalls 62 RAPTAR Laser Range Finders (Model G02) nationwide. The devices can be field-modified to enable higher-power visible and infrared lasers, posing eye injury risk from uncontrolled laser radiation.

    Product
    RAPTAR Laser Range Finders
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • ModerateFDA (Devices)·Z-0163-2022·2021-11-03

    Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number

    Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.

    Product
    Pneupac paraPac plus 300 ventilator kit, REF P300NGB
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0168-2022·2021-11-03

    GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date

    W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.

    Product
    REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0166-2022·2021-11-03

    GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date

    W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0167-2022·2021-11-03

    GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling

    GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.

    Product
    REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • ModerateFDA (Devices)·Z-0172-2022·2021-11-03

    Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling

    W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.

    Product
    REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
    Category
    Medical Device
    Distribution
    47 states
  • SevereFDA (Devices)·Z-0091-2022·2021-10-27

    Cardiosave Li-Ion battery pack recalled for insufficient runtime specification

    Datascope Corp. is recalling Cardiosave Li-Ion battery packs that failed to meet minimum runtime requirements. These nonconforming batteries were inadvertently released to customers worldwide.

    Product
    Cardiosave Li-Ion Battery Pack, Part No. 0146-00-0097. Component of the Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP) with the below Model Numbers. 1. Cardiosave Hybrid. Model Numbers: 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-35, 0998-00-0800-36, 099
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0107-2022·2021-10-27

    Infusion Pump Air Detector Malfunction May Prevent Alarm to Clinician

    Smiths Medical CADD-Solis VIP ambulatory infusion pumps may fail to detect air in the infusion line and alert clinicians due to intermittent air-detector malfunction.

    Product
    CADD-Solis VIP ambulatory infusion pump, Model Numbers: a. 21-2120-0105-02L b. 21-2120-0105-03L c. 21-2120-0105-06L d. 21-2120-0105-07L e. 21-2120-0105-08L f. 21-2120-0105-12L g. 21-2120-0105-13L h. 21-2120-0105-14L i. 21-2120-0105-15L j. 21-2120-0105-17L k. 21-2120-01
    Category
    Medical Device
    Distribution
    1 state
  • HighFDA (Devices)·Z-0134-2022·2021-10-27

    GE SIGNA Pioneer MRI Recall for Missing Image Slices

    GE Healthcare is recalling 5 SIGNA Pioneer MRI systems where a software issue can cause missing image slices in 3D volume scans. This may lead to diagnostic gaps.

    Product
    SIGNA Pioneer nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0138-2022·2021-10-27

    GE Healthcare SIGNA Voyager MRI System Recall for Missing Image Slices

    GE Healthcare is recalling the SIGNA Voyager nuclear magnetic resonance imaging system due to a software issue that can cause missing slices in 3D volume images, potentially creating gaps in anatomical information.

    Product
    SIGNA Voyager nuclear magnetic resonance imaging system
    Category
    Medical Device
    Distribution
    18 states
  • HighFDA (Devices)·Z-0124-2022·2021-10-27

    Atellica IM 1300 Analyzer Reagent Overflow at High Altitudes

    Siemens has recalled approximately 1,193 Atellica IM 1300 analyzers due to reagent overflow that occurs at altitudes above 350 meters, causing diagnostic test errors.

    Product
    Atellica IM 1300 Analyzer, SMN 11066001
    Category
    Medical Device
    Distribution
    23 states
  • HighFDA (Devices)·Z-0160-2022·2021-10-27

    Bone Screw Labeling Error: Actual Length May Not Match Package Label

    Limacorporate is recalling bone screws (REF 8420.15.010) because the actual length of the screws may not correspond to the length stated on the package label, potentially affecting proper surgical placement and implant stability.

    Product
    REF 8420.15.010, Bone Screw/Vite - Ti6AI4V, Self Tapping/Autofilettante, Dia=6.5mm, h=20mm, STERILE R, 2100099, UDI: (01)08033390018845
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0148-2022·2021-10-27

    CADD Administration Sets with Incorrect Air Filter Assembly

    Smiths Medical is recalling CADD Administration Sets (Model #21-7346-24) distributed in Canada because the air filter may have been assembled incorrectly. This manufacturing defect could impact device function.

    Product
    CADD Administration Sets, Model #21-7346-24
    Category
    Medical Device
    Distribution
    0 states