Fresenius Kabi USA, LLC recalls Ivenix Infusion System

Recalling company

Fresenius Kabi USA, LLC

Product

Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Reason

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.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

May 6, 2026

Reported

Jun 10, 2026

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;

Status

Ongoing

Quantity

18,444

Lot / codes

Model Number: LVP-0004; UDI-DI: 00811505030320; All Serial/Lot Numbers:

Company location

North Andover, MA

Recall type

Voluntary: Firm initiated

Recall number

Z-2224-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-2224-2026 in the FDA Enforcement Report. Also see FDA recall press releases.