Z-800W Infusion System — Class I medical device recall Z-1867-2025
Ongoing recall by Zyno Medical LLC, reported 2025-06-18, distributed nationwide. Unreleased software versions were installed on distributed devices without verification or validation.
| Recall number | Z-1867-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2025-05-07 |
| Classified | 2025-06-06 |
| Reported by FDA | 2025-06-18 |
| Distributed | Nationwide (US) |
| Quantity | 613 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814371020020 |
| Serial numbers | 700063, 700093, 700104, 700111, 700120, 700135, 700145, 700150, 700159, 700162, 700163, 700169, 700172, 700188, 700189, 700190, 700192, 700195, 700199, 700201, 700203, 700210, 700214, 700225, 700230 and 21 more |
| Model numbers | Z800W |
Product
Z-800W Infusion System. Intended to provide intravenous infusion of parenteral fluids, blood, and blood products to a patient.
Reason for recall
Unreleased software versions were installed on distributed devices without verification or validation.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1867-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.