Class I

Medical Device Recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Fresenius Kabi USA, LLC · May 6, 2026

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.

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.

States Affected

NATIONWIDE

Quantity Affected

32 systems

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2223-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Fresenius Kabi USA, LLC Medical Device Recall: LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. | SafeCheck