Medical Device Recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Fresenius Kabi USA, LLC · May 6, 2026
Reason for Recall
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
Distribution
Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
States Affected
CA, CO, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI
Quantity Affected
18,444
Source: FDA (openFDA Device Enforcement)
Recall number: Z-2224-2026
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.