FDA Medical devices recall ·
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2224-2026
- Date
- (initiated May 6, 2026)
- Company / brand
- Fresenius Kabi USA, LLC
50 High St Ste 50, North Andover, MA, United States - Category
- Medical devices › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 18,444
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004
Why was it recalled?
Fresenius Kabi has been made aware via customer complaints that dropping or severe jarring of the Ivenix LVP may cause damage to internal components that may not be apparent or readily visible and the devices therefore remained in service. More specifically, drops or jarring on a hard surface can cause the touchscreen input cable to loosen, resulting in unintended touchscreen behavior on the LVP, including random screen touches and/or lack of screen responsiveness to user input. Under the reported failure condition, unintended touch inputs may register at arbitrary screen locations without user interaction. These inputs occur intermittently and without a predictable pattern.
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; All Serial/Lot Numbers:
Distribution
Domestic: CA, CO, FL, GA, ID, IL, MD, MI, MI , MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI;
States: California Colorado Florida Georgia Idaho Illinois Maryland Michigan Minnesota Missouri Mississippi Nebraska New Jersey Nevada Oklahoma Oregon South Carolina Texas Virginia Washington Wisconsin
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (medical devices), recall Z-2224-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.