Z-800 Infusion System — Class II medical device recall Z-0506-2025
Ongoing recall by Zyno Medical LLC, reported 2024-11-27. Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current desp
| Recall number | Z-0506-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2024-10-18 |
| Classified | 2024-11-21 |
| Reported by FDA | 2024-11-27 |
| Quantity | 34,994 units |
| Reason classes | packaging |
| Lot numbers | 200406416, 20040660, 200413400, 200515888, 20071632, 200716968, 201016280, 201016720, 201208256, 201211360, 201211740, 2101221000, 210319640, 210709900, 210913200, 210913560, 220204548, 220205400, 2211141000, 230206980, 230420136, 230420548, 230525452, 230620200, 230620800, 230920212, 231008352 |
| Model numbers | Z-800, Z-800F, Z-800W, Z-800WF |
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.
Reason for recall
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
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-0506-2025. 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.