Ivenix Infusion System — Class II medical device recall Z-1048-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-01-21, distributed nationwide. Emphasizing instructions for LVP duration programming located in the IFU.
| Recall number | Z-1048-2026 |
|---|---|
| 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 | 2025-11-21 |
| Classified | 2026-01-12 |
| Reported by FDA | 2026-01-21 |
| Distributed | Nationwide (US) |
| Quantity | 30 units |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason for recall
Emphasizing instructions for LVP duration programming located in the IFU.
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-1048-2026. 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.