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 | Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains. |
| Product | Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient under the direction or supervision of a physician or other certified healthcare professional. |
| Quantity | 34,994 units |
| Distribution | This product is distributed only in the United States. |
| Initiated | 2024-10-18 |
| Classified | 2024-11-21 |
| Recall number | Z-0506-2025 |
| 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 II recall — Zyno Medical LLC (Z-0506-2025).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/95601/
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