Ivenix Infusion System — Class I medical device recall Z-0885-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-12-24, distributed in CA, CO, FL, GA, ID, IL, MD, MI…. Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or
| Recall number | Z-0885-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2025-11-14 |
| Classified | 2025-12-16 |
| Reported by FDA | 2025-12-24 |
| Distributed | CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI |
| Quantity | 30 units |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason for recall
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm 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-0885-2026. 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.