FDA recall, , Moderate risk
Fresenius Kabi Ivenix Infusion System Large Volume Pump
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) has a cassette loading lever that can break.
Summary by Recall Canary from the FDA notice
What happened
Fresenius Kabi USA, LLC, of North Andover, Massachusetts, recalled the Large Volume Pump (LVP) of the Ivenix Infusion System (IIS), Model Number LVP-0004, because the Cassette Loading Lever can break. The recall began on February 4, 2026, and was added to the FDA's Enforcement Report on May 29, 2026. The recall affects 18,444 installed bases distributed nationwide in 22 states, including California, Texas, 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?
Match the model number and UDI-DI listed under your product.
A UDI-DI is the device identifier printed with the barcode on the device label.
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS).
- Model
- LVP-0004
- UDI-DI
- 00811505030320
Recall details
- Company began the recall
- Sold in
US Nationwide distribution in the states of California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin.
- Company
- Fresenius Kabi USA, LLCNorth Andover, Massachusetts
- Hazard
- Device 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
- 98699
- Recall number
- Z-2274-2026
- Quantity recalled
- 18,444 installed bases
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
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
