FDA Medical devices recall ·
Plum Duo Infusion Pump, 40002-0401 recall
- Recall number
- Z-2312-2026
- Date
- (initiated April 29, 2026)
- Company / brand
- ICU Medical, Inc.
600 N Field Dr, Lake Forest, IL, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 13,613
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Plum Duo Infusion Pump, 40002-0401
Why was it 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 you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
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.
States: Idaho Illinois Indiana Kansas Massachusetts Maryland New Mexico New York Pennsylvania Tennessee Texas
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-2312-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.