FDA Medical devices recall ·
LVP software of the Ivenix Infusion System (IIS) recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-2223-2026
- 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
- 32 systems
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Why was it recalled?
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
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
Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
Distribution
US Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, 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-2223-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.