Recall Z-2724-2026— ICU Medical, Inc.

Name: FDA recall Z-2724-2026
Creator: U.S. Food and Drug Administration
Published: 2026-06-10

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2026-06-10. It names one FDA 510(k) clearance: K242114. Product: ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump. Reason: In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-06-10
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K242114 — Plum Solo Precision IV PumpIcu Medical, Inc.·cleared 2025-04-02

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

ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number 400010401; infusion pump

Reason for recall

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

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