Ivenix Infusion System — Class II medical device recall Z-0848-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2025-12-10, distributed nationwide. Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is a
| Recall number | Z-0848-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2025-11-03 |
| Classified | 2025-12-01 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 15,862 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Model numbers | LVP-0004 |
Product
Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Reason for recall
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
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-0848-2026. 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.