Recall Z-1094-2026— ICU Medical, Inc.

Name: FDA recall Z-1094-2026
Creator: U.S. Food and Drug Administration
Published: 2025-12-15

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2025-12-15. It names one FDA 510(k) clearance: K223607. Product: Plum Duo Infusion System, List Number 40002-04-01. Reason: 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..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2025-12-15
Firm location: Lake Forest, IL, United States

510(k) clearances named in this recall

1 on FDA's record

K223607 — Plum Duo Infusion SystemIcu Medical, Inc.·cleared 2023-08-24

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

Plum Duo Infusion System, List Number 40002-04-01

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.

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