FDAClass I · Medical device · Recalled June 10, 2026

LVP software of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Hazard: 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.

Class I: most serious — reasonable probability of serious health consequences or death.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2223-2026
Brand: Fresenius Kabi USA
Classification: Class I
Units affected: 32 systems
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005.

Affected products

LVP software of the Ivenix Infusion System (IIS)

Companies & origin

Recalling firm location: North Andover, MA, United States
Firm address: 50 High St Ste 50, 01845-2620

Identifying details (verbatim from the notice)

Product codes / lots: Product Code LVP-SW-0005. UDI-DI: 00811505030122. Software Version 5.10.2
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.
Firm notified the public via: Letter
FDA event ID: 98929
Recall initiated: May 6, 2026
FDA classified: June 3, 2026
FDA report date: June 10, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 3:00 AM UTC.

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