Zyno Medical LLC Recalls

All product recalls associated with Zyno Medical LLC.

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Recall Summary

Total Recalls

9

Past Year

4

Class I (Serious)

0

Most Recent

May 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–9 of 9 recalls

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

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

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

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

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Z-800W Infusion System (Zyno Medical) – Unreleased Software (2025)

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

Moderate

FDAMay 7, 2025Nationwide

• Zyno Medical LLC

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

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

Moderate

FDAMay 7, 2025Nationwide• Zyno Medical LLC

Z-800 Infusion System (Zyno Medical) – Battery Discharge (2024)

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

Moderate

FDAOct 18, 2024Nationwide• Zyno Medical LLC

Z-800 Infusion System (Zyno Medical) – WiFi Software Compatibility (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.

Moderate

FDASep 30, 2024AL, FL, LA +5 more• Zyno Medical LLC

Z-800 Infusion System (Zyno Medical) – Air-in-Line Software Defect (2024)

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

Moderate

FDASep 13, 2024Nationwide• Zyno Medical LLC

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

Moderate

FDAJun 4, 2024Nationwide• Zyno Medical LLC

Zyno Medical LLC: Zyno Medical Z800 Large Volume Infusion Pumps -Intended t...

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 therapy and in extreme cases, associated risk of organ failure or death

Very High

FDADec 20, 2023Nationwide• Zyno Medical LLC

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Zyno Medical LLC Recalls

Recall Summary

Z-800WF Infusion System (Zyno Medical) – Unreleased Software (2025)

Z-800F Infusion System (Zyno Medical) – Unreleased Software (2025)

Z-800W Infusion System (Zyno Medical) – Unreleased Software (2025)

Z-800 Infusion System (Zyno Medical) – Unreleased Software (2025)

Z-800 Infusion System (Zyno Medical) – Battery Discharge (2024)

Z-800 Infusion System (Zyno Medical) – WiFi Software Compatibility (2024)

Z-800 Infusion System (Zyno Medical) – Air-in-Line Software Defect (2024)

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

Zyno Medical LLC: Zyno Medical Z800 Large Volume Infusion Pumps -Intended t...