FDA Device recall Z-1868-2025
Z-800WF Infusion System
- FDA Device
- Class I
- ongoing
- Published 2025-06-18
On 2025-06-18 the FDA classified a Class I recall of Z-800WF Infusion System by Zyno Medical, citing unreleased software versions were installed on distributed devices without verification or validation.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1868-2025 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-05-07 |
| Published | 2025-06-18 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Zyno Medical |
| Distribution | US |
Product
Z-800WF Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason
Unreleased software versions were installed on distributed devices without verification or validation.
Identifiers
| code_info | Model No. Z800WF; UDI-DI: 00814371020037; Serial No. 500004; 500005; 500006; 500810; 500812; 500813; 501748; 503680; 503681; 503682. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1868-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.