Recall Z-2312-2026— ICU Medical, Inc.

Name: FDA recall Z-2312-2026
Creator: U.S. Food and Drug Administration
Published: 2026-04-29

Class II · Ongoing

Class II FDA medical device recall by ICU Medical, Inc., initiated 2026-04-29. It names one FDA 510(k) clearance: K223607. Product: Plum Duo Infusion Pump, 40002-0401. Reason: Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery..

Recalling firm: ICU Medical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2026-04-29
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 Pump, 40002-0401

Reason for recall

Under certain conditions, the pump may not display a soft limit alert, and will not notify the clinician of a soft limit violation before confirming and starting delivery. This may potentially lead to under- or over-delivery.

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