Class II

Medical Device Recall: Plum Duo Infusion System, List Number 40002-04-01

ICU Medical, Inc. · December 15, 2025

Reason for Recall

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.

Distribution

Worldwide - US Nationwide distribution.

States Affected

NATIONWIDE

Quantity Affected

423 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-1094-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.