FDA recall Z-2223-2026

Product

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.

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.

Key facts

Status

Ongoing

Initiation date

2026-05-06

Report date

2026-06-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Andover, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2223-2026