Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide… — Class II medical device recall Z-1183-2024
Ongoing recall by Zyno Medical LLC, reported 2024-03-06, distributed nationwide. When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the al
| Recall number | Z-1183-2024 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zyno Medical LLC, Natick, MA, United States |
| Recall initiated | 2023-12-20 |
| Classified | 2024-02-23 |
| Reported by FDA | 2024-03-06 |
| Distributed | Nationwide (US) |
| Quantity | 574 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00814371020037 |
| Model numbers | Z-800WF |
Product
Zyno Medical Z800 Large Volume Infusion Pumps -Intended to provide intravenous infusion of parenteral fluids, blood and blood products to a patient under the direction or supervision of physician or other certified health care professional Model: Z-800WF
Reason for recall
When utlizing the patient query feature on the Zyno Medical Z-800WF pumps with software version 5.2.05, the alarm volume may inadvertently revert from a higher volume setting to a low one, causing potential delays in therapy and in extreme cases, associated risk of organ failure or death
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-1183-2024. 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.