FDA recall, , Moderate risk
Fresenius Kabi Ivenix Infusion System LVP Software
The Ivenix Infusion System LVP Software has instructions for LVP duration programming that are emphasized in the IFU.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Kabi USA, LLC of North Andover, Massachusetts is recalling 30 units of the Ivenix Infusion System (IIS) LVP Software: LVP-SW-0005. The agency stated the reason is emphasizing instructions for LVP duration programming located in the IFU. The company began the recall on November 21, 2025, and it was added to the FDA's Enforcement Report on January 12, 2026.
Distribution was nationwide in states including California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Affected if its UDI-DI matches.
A UDI-DI is the device identifier printed with the barcode on the device label.
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
- UDI-DI
- 00811505030122
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin, Wisconsin.
- Company
- Fresenius Kabi USA, LLCNorth Andover, Massachusetts
- Hazard
- Software defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98106
- Recall number
- Z-1048-2026
- Quantity recalled
- 30 units
All recalls from Fresenius Kabi USA, LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary