Zyno Medical LLC: Device Recall

Recall #Z-2263-2024 · 06/04/2024

Class II: Risk

Recall Details

Recall Number: Z-2263-2024
Classification: Class II
Product Type: Device
Recalling Firm: Zyno Medical LLC
Status: Ongoing
Date Initiated: 06/04/2024
Location: Natick, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 88 units

Reason for Recall

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.

Product Description

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

Distribution Pattern

US Nationwide distribution.

Other Recalls by Zyno Medical LLC

Class I: Dangerous 05/07/2025

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

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

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

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

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

View all recalls by Zyno Medical LLC →

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.