FDA Device recall Z-2274-2026
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004
- FDA Device
- Class II
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class II recall of The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004 by Fresenius Kabi Usa, citing potential for the Cassette Loading Lever to break.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2274-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-04 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Reason
Potential for the Cassette Loading Lever to break.
Identifiers
| code_info | Model Number: LVP-0004. UDI-DI: 00811505030320 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2274-2026%22
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