FDA Device recall Z-2223-2026
LVP software of the Ivenix Infusion System (IIS)
- FDA Device
- Class I
- ongoing
- Published 2026-06-10
On 2026-06-10 the FDA classified a Class I recall of LVP software of the Ivenix Infusion System (IIS) by Fresenius Kabi Usa, citing potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2223-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2026-05-06 |
| Published | 2026-06-10 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Fresenius Kabi Usa |
| Distribution | US |
Product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
Identifiers
| code_info | Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
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FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius K…
FDA Drug · Class II · 2026-07-29 · Fresenius Kabi Usa - Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi…
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-2223-2026%22
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