Recall Atlas

Zyno Medical recalls

6 official recalls and safety alerts involving Zyno Medical since 2024-03, 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 Zyno Medical or the relevant agency.

  1. 2025-06-18
  2. US
    Drugs & medicalClass I

    Zyno Medical LLC recalls Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.

    Unreleased software versions were installed on distributed devices without verification or validation.

    FDA · DeviceZyno Medical LLCUS NationwideOfficial notice →
  3. 2024-12-04
  4. US
    Drugs & medicalClass III

    Zyno Medical LLC recalls Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is intended to provide…

    For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.

    FDA · DeviceZyno Medical LLCDomestic: AL, FL, LA, MI, NE, NJ, OH, TX.Official notice →
  5. 2024-11-27
  6. US
    Drugs & medicalClass II

    Zyno Medical LLC recalls Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous…

    Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.

    FDA · DeviceZyno Medical LLCThis product is distributed only in the United States.Official notice →
  7. 2024-10-16
  8. US
    Drugs & medicalClass I

    Zyno Medical LLC recalls Z-800 Infusion System, Model Numbers Z-800, Z-800F, Z-800W, Z-800WF; Software Version: Z-800 6.1.01 and 6-1.07z; Z-800F 4.1.02 and…

    There is a defect in the air-in-line software algorithm.

    FDA · DeviceZyno Medical LLCUS Nationwide.Official notice →
  9. 2024-07-10
  10. US
    Drugs & medicalClass II

    Zyno Medical LLC recalls Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps

    Zyno Medical has found that certain Z800, Z800F, Z800W, and Z800WF pumps have faulty power supply modules that will not provide a charge to the rechargeable battery within the pump. This may lead to the battery having…

    FDA · DeviceZyno Medical LLCUS Nationwide distribution.Official notice →
  11. 2024-03-06
  12. US
    Drugs & medicalClass II

    Zyno Medical LLC recalls Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to…

    When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in…

    FDA · DeviceZyno Medical LLCNationwideOfficial notice →