FDA Medical devices recall ·
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall
- Recall number
- Z-2274-2026
- Date
- (initiated February 4, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 18,444 installed bases
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Why was it recalled?
Potential for the Cassette Loading Lever to break.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: LVP-0004. UDI-DI: 00811505030320
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.
States: California Colorado Florida Georgia Idaho Illinois Massachusetts Maryland Maine Michigan Minnesota Mississippi Nebraska New Jersey Nevada Oklahoma Oregon South Carolina Texas Virginia Washington Wisconsin
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2274-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.