Zyno Medical LLC

8 FDA enforcement actions

8 Total Recalls

5 Class I

2 Class II

1 Class III

Firm Details

Product Types: device
States: MA

All Recalls

Class I: Dangerous 05/07/2025 device

Unreleased software versions were installed on distributed devices without verification or validation.
Class I: Dangerous 05/07/2025 device

Unreleased software versions were installed on distributed devices without verification or validation.
Class I: Dangerous 05/07/2025 device

Unreleased software versions were installed on distributed devices without verification or validation.
Class I: Dangerous 05/07/2025 device

Unreleased software versions were installed on distributed devices without verification or validation.
Class II: Risk 10/18/2024 device

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
Class III: Low Risk 09/30/2024 device

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.
Class I: Dangerous 09/13/2024 device

There is a defect in the air-in-line software algorithm.
Class II: Risk 06/04/2024 device

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 insufficient or no charge available to the pump when it is unplugged from the AC mains power.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.