Class I — Zyno Medical LLC
| Recalling firm | Zyno Medical LLC. |
|---|---|
| Registered facility | Zyno Medical LLC. (the firm's only registered facility) |
| Classification | Class I |
| Status | Ongoing |
| Reason | Unreleased software versions were installed on distributed devices without verification or validation. |
| Product | Z-800F Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient. |
| Quantity | 613 units |
| Distribution | US Nationwide |
| Initiated | 2025-05-07 |
| Classified | 2025-06-06 |
| Recall number | Z-1866-2025 |
| 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 I recall — Zyno Medical LLC (Z-1866-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/96796/
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