Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
Medical deviceClass IIOngoing
Summary: Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.. Reason: Emphasizing instructions for LVP duration programming located in the IFU.
What is being recalled
Ivenix Infusion System (IIS), LVP Software: LVP-SW-0005.
Why
Emphasizing instructions for LVP duration programming located in the IFU.
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, MD, MI, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI, WI. (states named: California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Mississippi, Nebraska, New Jersey, Nevada, Oklahoma, Oregon, South Carolina, Texas, Virginia, Washington, Wisconsin)
How to tell if yours is affected
Product Code: LVP-SW-0005; UDI: 00811505030122; Software versions 5.10.2 and prior.
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-1048-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | November 21, 2025 |
| Reported | January 21, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | North Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 30 units |
More recalls from Fresenius Kabi USA, LLC · all medical device recalls · recalls from November 2025