Fresenius Kabi USA, LLC recalls Ivenix Infusion System
- Recalling company
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
- Reason
- Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
- Classification
- Class I – a reasonable probability that use will cause serious adverse health consequences or death
- Recall date
- Nov 14, 2025
- Reported
- Dec 24, 2025
- Distribution
- US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
- Status
- Ongoing
- Quantity
- 30 units
- Lot / codes
- Software Versions 5.10.1 and prior; UDI: 00811505030122.
- Company location
- North Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-0885-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-0885-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.