The Large Volume Pump — Class II medical device recall Z-2274-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-06-10, distributed nationwide. Potential for the Cassette Loading Lever to break.
| Recall number | Z-2274-2026 |
|---|---|
| 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 | 2026-02-04 |
| Classified | 2026-05-29 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 18,444 installed |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 00811505030320 |
| Model numbers | LVP-0004 |
Product
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Reason for recall
Potential for the Cassette Loading Lever to break.
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-2274-2026. 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.