Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
Medical deviceClass IOngoing
Summary: Fresenius Kabi USA, LLC is recalling Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.. Reason: Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
What is being recalled
Ivenix Infusion System (IIS), LVP Software LVP-SW-0005. Software for the controlled administration of fluids to patients.
Why
Software version 5.10.1 and earlier contain anomalies that have the potential to cause serious patient harm or death.
How serious is it
Class I is the most serious level: FDA considers there is a reasonable probability that using or being exposed to this product will cause serious health problems or death.
Where it was sold
US (Domestic) distribution: CA, CO, FL, GA, ID, IL, MD, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA & 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
Software Versions 5.10.1 and prior; UDI: 00811505030122.
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-0885-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | November 14, 2025 |
| Reported | December 24, 2025 |
| 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