Zyno Medical LLC: Device Recall

Recall #Z-0506-2025 · 10/18/2024

Class II: Risk

Recall Details

Recall Number: Z-0506-2025
Classification: Class II
Product Type: Device
Recalling Firm: Zyno Medical LLC
Status: Ongoing
Date Initiated: 10/18/2024
Location: Natick, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 34,994 units

Reason for Recall

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

Product Description

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 infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional.

Distribution Pattern

This product is distributed only in the United States.

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 III: Low Risk 09/30/2024

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.

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.