FDAClass IIJune 17, 2026

Plum Duo Infusion Pump recall

Plum Duo Infusion Pump, 40002-0401

Why was Plum Duo Infusion Pump recalled?

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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3

Product
Plum Duo Infusion Pump, 40002-0401
Recalling firm
ICU Medical, Inc.
Quantity
13,613
Distribution
Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
Recall date
June 17, 2026
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls