Critical Alert
Fresenius Kabi USA Recalls LVP software of the Ivenix Infusion System (IIS)
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #Z-2223-2026Medical Device
Fresenius Kabi USA Recalls LVP software of the Ivenix Infusion System (IIS)
Fresenius Kabi USA, LLC · Class I — Most Serious
Product Description
LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.
Reason for Recall
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.
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
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.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Fresenius Kabi USA, LLC is recalling a medical device classified as Class I by the FDA — the highest risk level. The recall was initiated on May 6, 2026 affecting 32 systems. 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. It was distributed in CA, CO, FL, GA, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Fresenius Kabi USA recalls.