Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System
- Recalling company
- Fresenius Kabi USA, LLC
- 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.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- May 6, 2026
- Reported
- Jun 10, 2026
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Status
- Ongoing
- Quantity
- 32 systems
- Lot / codes
- Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
- Company location
- North Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2223-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2223-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.