Class II — Zyno Medical LLC
| Recalling firm | Zyno Medical LLC. |
|---|---|
| Registered facility | Zyno Medical LLC. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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 |
| Product | Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF |
| Quantity | 574 units |
| Distribution | Nationwide |
| Initiated | 2023-12-20 |
| Classified | 2024-02-23 |
| Recall number | Z-1183-2024 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Zyno Medical LLC (Z-1183-2024).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/93857/
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