FDA Device recall Z-0885-2026
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005
- FDA Device
- Class I
- ongoing
- Published 2025-12-24
On 2025-12-24 the FDA classified a Class I recall of Ivenix Infusion System (IIS), LVP Software LVP-SW-0005 by Fresenius Kabi Usa, citing software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0885-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-11-14 |
| Published | 2025-12-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI |
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Reason
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Identifiers
| code_info | Software Versions 5.10.1 and prior; UDI: 00811505030122. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa
All Fresenius Kabi Usa recalls
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0885-2026%22
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