FDA recall record · openFDA

Zyno Medical LLC

9 FDA recalls on record (2023–2025) — 9 device. 9 still ongoing.

Class I (most serious)

Class II

Class III

ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Unreleased software versions were installed on distributed devices without verification or validation. 4

Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being 1

For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance wi 1

There is a defect in the air-in-line software algorithm. 1

When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume 1

Recalls

Z-800 Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pat Class I 2025-05-07 Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a p Class I 2025-05-07 Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa Class I 2025-05-07 Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a pa Class I 2025-05-07 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 Class I 2024-09-13 Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended Class II 2024-10-18 Zyno Medical Z800, Z800F, Z800W, and Z800WF Infusion Pumps Class II 2024-06-04 Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and Class II 2023-12-20 Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: Z-800WF. The Z-800 Infusion system is i Class III 2024-09-30

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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