FDA-Device2025-12-24Class IPROCESSING DEFECT
Fresenius Kabi Ivenix Infusion System software recalled for patient safety anomalies
What this means
Fresenius Kabi has recalled software version 5.10.1 and earlier for the Ivenix Infusion System due to anomalies that could cause serious patient harm. The affected software is used to control the delivery of fluids to patients in medical settings. About 30 units have been distributed across multiple U.S. states.
- If your facility uses the Ivenix Infusion System, update to software version 5.10.2 or later immediately
- Do not use affected software version 5.10.1 or earlier for patient care
- Contact Fresenius Kabi for update instructions and technical support
The agency's original wording
Hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
Intended for
Adults
Illnesses reported
None reported
Sold states
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
Affected count
30 units
Manufactured in
50 High St Ste 50, North Andover, MA, United States
Products
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0885-2026More Fresenius Kabi recalls
- FDA-Drug2026-07-29Fresenius Kabi glycopyrrolate injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Xylocaine lidocaine injection recalled for hair contamination
- FDA-Drug2026-07-29Fresenius Kabi Naropin injection recalled for hair contamination
Want us to check the next one for you?
We read every CPSC, FDA, USDA, and NHTSA notice and email you a plain-English Sunday brief covering your household — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.