FDA-Device2025-12-24Class IPROCESSING DEFECT
Fresenius Kabi Ivenix Infusion System software recalled for patient safety anomalies
Update Ivenix Infusion System software immediately
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
Hazard
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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 USA, LLC recalls
- FDA-Drug2026-06-17Fresenius Kabi epinephrine injection recalled for failed impurity specifications
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility assurance
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for sterility concerns
- FDA-Drug2026-04-15Fresenius Kabi sodium chloride injection recalled for lack of sterility assurance
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