FDAClass II · Medical device · Recalled June 10, 2026

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS) recall — Fresenius Kabi USA, LLC

Hazard: Potential for the Cassette Loading Lever to break.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: Z-2274-2026
Brand: Fresenius Kabi USA
Classification: Class II
Units affected: 18,444 installed bases
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

The Large Volume Pump (LVP) of the Ivenix Infusion System (IIS). Model Number: LVP-0004.

Affected products

The Large Volume Pump (LVP) 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: Model Number: LVP-0004. UDI-DI: 00811505030320
Distribution: US Nationwide distribution in the states of CA, CO, FL, GA, ID, IL, MA, MD, ME, MI, MN, MS, NE, NJ, NV, OK, OR, SC, TX, VA, WA, WI.
Firm notified the public via: E-Mail
FDA event ID: 98699
Recall initiated: February 4, 2026
FDA classified: May 29, 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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