FDA Device recall Z-1048-2026
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005
- FDA Device
- Class II
- ongoing
- Published 2026-01-21
On 2026-01-21 the FDA classified a Class II recall of Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005 by Fresenius Kabi Usa, citing emphasizing instructions for LVP duration programming located in the IFU.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1048-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-11-21 |
| Published | 2026-01-21 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Reason
Emphasizing instructions for LVP duration programming located in the IFU.
Identifiers
| code_info | Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior. |
|---|
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-1048-2026%22
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