Class II

Medical Device Recall: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Fresenius Kabi USA, LLC · February 4, 2026

Reason for Recall

Potential for the Cassette Loading Lever to break.

Distribution

US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.

States Affected

NATIONWIDE

Quantity Affected

18,444 installed bases

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2274-2026

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: The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004. | SafeCheck