fda_recall · device_recall · critical

Fresenius Kabi USA, LLC — Class I recall: Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004

Event date
2026-06-10 00:00:00Z
Observed
2026-07-09 22:52:23Z
Source ID
Z-2224-2026
Payload hash
19818286590ba341094f2bc0

Summary

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 ca… Status: Ongoing.

Informational only. Not legal, financial, or medical advice.