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 | There is a defect in the air-in-line software algorithm. |
| Product | 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 |
| Quantity | 34,994 units (1819 units still need correction) |
| Distribution | US Nationwide. |
| Initiated | 2024-09-13 |
| Classified | 2024-10-09 |
| Recall number | Z-0005-2025 |
| 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-0005-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95382/
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