Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Plum Duo Infusion System Recalled by ICU Medical, Inc. Due to ICU Medical received one lot of defective primary...

Date: December 15, 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 40002-04-01

Quantity: 423 units

Why Was This Recalled?

ICU Medical received one lot of defective primary speakers from our supplier that may fail to produce an audible sound. If the primary speaker in your Plum Duo Infusion Pump fails, the pump may not produce audible alarms, alerts, or provide audible feedback for touchscreen inputs.

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