LVP software of the Ivenix Infusion System recall (Fresenius Kabi USA, LLC)
Medical deviceClass IOngoing
Summary: Fresenius Kabi USA, LLC is recalling LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.. Reason: Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
What is being recalled
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Why
Potential software anomaly that can cause the pump to report a false battery-health value (typically 69%) and trigger a battery-depletion alarm that will shut down the pump unless it is reconnected to AC mains power.
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 Nationwide distribution in the states of CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI. (states named: California, Colorado, Florida, Georgia, Idaho, Illinois, Maryland, Michigan, Minnesota, Missouri, 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-DI: 00811505030122. Software Version 5.10.2
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-2223-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class I |
| Status | Ongoing |
| Recall started | May 6, 2026 |
| Reported | June 10, 2026 |
| Company | Fresenius Kabi USA, LLC |
| Company location | North Andover, MA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 32 systems |
More recalls from Fresenius Kabi USA, LLC · all medical device recalls · recalls from May 2026