Recall Atlas

Cook Medical recalls

4 official recalls and safety alerts involving Cook Medical since 2022-04, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.

This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Cook Medical or the relevant agency.

  1. 2025-10-22
  2. US
    Drugs & medicalClass I

    Cook Medical Incorporated recalls Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2- Reference Part Numbers ZTA2-P-40-117-W ZTA2-P-40-167 ZTA2-P-40-167-W…

    Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.

    FDA · DeviceCook Medical IncorporatedDomestic distribution to AL AR AZ CA CT DC DE FL GA IL IN LA MA MD MI MN MO NC…Official notice →
  3. 2024-05-22
  4. US
    Drugs & medicalClass II

    Cook Medical Incorporated recalls EchoTip¿ Ultra HD Endoscopic Ultrasound Access Needle, ECHO-HD-19-A, G52012

    Devices may contain elevated levels of bacterial endotoxin.

    FDA · DeviceCook Medical IncorporatedInternational distribution in the countries of Germany, Netherlands,…Official notice →
  5. 2024-01-24
  6. US
    Drugs & medicalClass II

    Cook Medical Llc recalls MINC+ Benchtop Incubator, Reference Part Number (RPN) K-MINC-2000, Order Number (GPN) G44429

    The MINC+ device is susceptible to losing temperature control of electrostatic discharge (static electricity) is applied to the lid of the device. This may lead to embryo degeneration necessitating an additional…

    FDA · DeviceCook Medical LlcDomestic distribution to CA IN LA MD NY International distribution to…Official notice →
  7. 2022-04-13
  8. US
    Drugs & medicalClass III

    Cook Medical Incorporated recalls Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach Catalog Number/GPN: IGTCFS-65-1-FEM-TULIP G52917; IGTCFS-65-1-JUG-TULIP…

    IFU update includes an update to the Device description, Intended Use/Indications for Use, Contraindications, Warnings, Precautions, Potential adverse events

    FDA · DeviceCook Medical IncorporatedUS Nationwide - Worldwide Distribution Foreign: Canada, Bahamas ,Chile GuamOfficial notice →