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Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients
Recalled December 24, 2025 · FDA recall Z-0885-2026 · Fresenius Kabi USA
Hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death. · FDA Class I
Units
30 units
Sold at
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Description
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Manufacturer(s)
Fresenius Kabi USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →