Fresenius Kabi USA, LLC recalls Ivenix Infusion System
- Recalling company
- Fresenius Kabi USA, LLC
- Product
- Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- Reason
- Emphasizing instructions for LVP duration programming located in the IFU.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Nov 21, 2025
- Reported
- Jan 21, 2026
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI.
- Status
- Ongoing
- Quantity
- 30 units
- Lot / codes
- Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
- Company location
- North Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-1048-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-1048-2026 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.