FDAClass I · Medical device · Recalled June 10, 2026
Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC
Hazard: 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.
Class I: most serious — reasonable probability of serious health consequences or death.
View the official FDA enforcement record (openFDA) ↗
Description
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Affected products
Companies & origin
Identifying details (verbatim from the notice)
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.