FDA Medical devices recall ·
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- Z-0885-2026
- Date
- (initiated November 14, 2025)
- 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
- 30 units
- Hazard tags
- Software
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Why was it recalled?
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
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
Software Versions 5.10.1 and prior; UDI: 00811505030122.
Distribution
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & WI.
States: California Colorado Florida Georgia Idaho Illinois Maryland Michigan Minnesota 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-0885-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.