Fresenius Kabi USA, LLC recalls The Large Volume Pump
- Recalling company
- Fresenius Kabi USA, LLC
- Product
- The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
- Reason
- Potential for the Cassette Loading Lever to break.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Feb 4, 2026
- Reported
- Jun 10, 2026
- Distribution
- US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
- Status
- Ongoing
- Quantity
- 18,444 installed bases
- Lot / codes
- Model Number: LVP-0004. UDI-DI: 00811505030320
- Company location
- North Andover, MA
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2274-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2274-2026 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.