Class I — Serious Health Hazard

Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.

Plum Duo Infusion System Recalled by ICU Medical, Inc. Due to ICU Medical identified two sequences of programming events...

Date: July 11, 2025
Company: ICU Medical, Inc.
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact ICU Medical, Inc. directly.

Affected Products

Plum Duo Infusion System, List Number: 400020401

Quantity: 4677 units

Why Was This Recalled?

ICU Medical identified two sequences of programming events and alarm interactions that may cause the user interface to become unresponsive.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About ICU Medical, Inc.

ICU Medical, Inc. has 592 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report