Fresenius Kabi Ivenix Infusion System (IIS), Large Volume Pump
The Ivenix Large Volume Pump can be damaged by dropping or jarring, causing unintended touchscreen behavior.
High risk
There is a reasonable chance that using it could cause serious health problems or death.
FDA Class I recall · How risk is rated
What happened
Fresenius Kabi USA, LLC, of North Andover, Massachusetts, recalled the Ivenix Infusion System (IIS) Large Volume Pump, Model Number LVP-0004, after customer complaints showed 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. The agency stated that drops or jarring on a hard surface can cause the touchscreen input cable to loosen.
The recall began May 6, 2026, and was added to the FDA's Enforcement Report on May 29, 2026. The devices were distributed domestically in California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington and Wisconsin.
Summary by Recall Canary from the FDA notice.
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.
Ivenix Infusion System (IIS), Large Volume Pump
- Model
- LVP-0004
- UDI-DI
- 00811505030320
Details
- Company began the recall
- Sold in
Domestic: California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Michigan , Minnesota, Missouri, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin, Wisconsin;
- Event ID
- 98945
- Recall No.
- Z-2224-2026
- Company
- Fresenius Kabi USA, LLCNorth Andover, Massachusetts
- Hazard
- Device defect
- Recall type
- Voluntary: Firm initiated
- Customers told by
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
