The Large Volume Pump recall (Fresenius Kabi USA, LLC)
Medical deviceClass IIOngoing
Summary: Fresenius Kabi USA, LLC is recalling The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.. Reason: Potential for the Cassette Loading Lever to break.
What is being recalled
The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.
Why
Potential for the Cassette Loading Lever to break.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI. (states named: California, Colorado, Florida, Georgia, Idaho, Illinois, Massachusetts, Maryland, Maine, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin)
How to tell if yours is affected
Model Number: LVP-0004. UDI-DI: 00811505030320
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2274-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 4, 2026 |
| Reported | June 10, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | North Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 18,444 installed bases |
More recalls from Fresenius Kabi USA, LLC · all medical device recalls · recalls from February 2026