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Fresenius Kabi USA, LLC recalls LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Recalled June 10, 2026 · FDA recall Z-2223-2026 · Fresenius Kabi USA
Hazard
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. · FDA Class I
Units
32 systems
Sold at
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.
Description
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.
Product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →