Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog… — Class III medical device recall Z-0523-2025
Ongoing recall by Zyno Medical LLC, reported 2024-12-04, distributed in AL, FL, LA, MI, NE, NJ, OH, TX. For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in acc
| Recall number | Z-0523-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2024-09-30 |
| Classified | 2024-11-22 |
| Reported by FDA | 2024-12-04 |
| Distributed | AL, FL, LA, MI, NE, NJ, OH, TX |
| Quantity | 100 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814371020006 |
| Serial numbers | 500346, 500347, 500348, 500349, 500350, 500351, 500352, 500353, 500354, 500355, 500356, 500357, 500358, 500359, 500360, 500361, 500362, 500363, 500364, 500365, 500367, 500368, 500369, 500370, 500371 and 75 more |
| Model numbers | Z-800, Z-800WF |
Product
Brand Name: Z-800 Infusion System Product Name: Z-800WF Model/Catalog Number: 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 physician or other certified healthcare professional.
Reason for recall
For the Z-800WF pumps, the WiFi software was not compatible with the pump software that had been loaded in accordance with ongoing correction Z-1183-2024.
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-0523-2025. 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.