Fresenius Kabi Usa, Llc: Pump, Infusion
Recall Summary Fresenius Kabi is recalling the LVP software in their Ivenix Infusion System pumps due to a software issue that can cause the pump to incorrectly display battery health at 69% and shut down with a false battery alarm, requiring reconnection to AC power to restart. The affected product is distributed nationwide across the United States. This is a Class II recall, indicating a potential serious health consequence.
- Recalling firm
- Fresenius Kabi USA, LLC
- Product
- 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.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-05-06
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- 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.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/e7d4f520-f288-4eb0-8d6d-a676e1805bb5