Zyno Medical LLC: Device Recall

Recall #Z-0005-2025 · 09/13/2024

Class I: Dangerous

Recall Details

Recall Number: Z-0005-2025
Classification: Class I
Product Type: Device
Recalling Firm: Zyno Medical LLC
Status: Ongoing
Date Initiated: 09/13/2024
Location: Natick, MA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 34,994 units (1819 units still need correction)

Reason for Recall

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

Product Description

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 4.1.08z; Z-800W 3.1.32 and 3.1.64z, Z-800WF 3.1.32 and 3.1.64z

Distribution Pattern

US Nationwide.

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.