LVP software of the Ivenix Infusion System — Class I medical device recall Z-2223-2026
Ongoing recall by Fresenius Kabi USA, LLC, reported 2026-06-10, distributed nationwide. Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and
| Recall number | Z-2223-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, North Andover, MA, United States |
| Recall initiated | 2026-05-06 |
| Classified | 2026-06-03 |
| Reported by FDA | 2026-06-10 |
| Distributed | Nationwide (US) |
| Quantity | 32 systems |
| Reason classes | software |
| UPC / GTIN / UDI-DI | 00811505030122 |
Product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason for recall
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.
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-2223-2026. 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.