Z-800 Infusion System — Class I medical device recall Z-0005-2025
Ongoing recall by Zyno Medical LLC, reported 2024-10-16, distributed nationwide. There is a defect in the air-in-line software algorithm.
| Recall number | Z-0005-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2024-09-13 |
| Classified | 2024-10-09 |
| Reported by FDA | 2024-10-16 |
| Distributed | Nationwide (US) |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814371020006, 00814371020013, 00814371020020, 00814371020037 |
| Lot numbers | 190722360, 20110921-SH, 20111005-SH, 20111102-SH, 20111212-SH, 20120105-SH, 20120222-SH, 20120417-SH, 20120501-SH, 20120612-SH, 20120719-SH, 20120809-SH, 20120910-SH-1, 20121213-SH, 20130123-SH, 20130227-SH, 20130511-SH, 20130517-SH, 20130609-SH, 20130701-SH, 20130812-SH, 20131024-SH, 20190809-SH |
| Model numbers | Z-800, Z-800F, Z-800W, Z-800WF |
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
Reason for recall
There is a defect in the air-in-line software algorithm.
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-0005-2025. 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.