Recall Z-2223-2026— Fresenius Kabi USA, LLC

Name: FDA recall Z-2223-2026
Creator: U.S. Food and Drug Administration
Published: 2026-05-06

Class I · Ongoing

Class I FDA medical device recall by Fresenius Kabi USA, LLC, initiated 2026-05-06. It names one FDA 510(k) clearance: K183311. 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..

Recalling firm: Fresenius Kabi USA, LLC
Classification: Class I
Status: Ongoing
Initiated: 2026-05-06
Firm location: North Andover, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K183311 — Ivenix Infusion System (IIS)Ivenix, Inc.·cleared 2019-06-07

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.