ICU Medical, Inc. recalls Plum Duo Infusion Pump
- Recalling company
- ICU Medical, Inc.
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Apr 29, 2026
- Reported
- Jun 17, 2026
- 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.
- Status
- Ongoing
- Quantity
- 13,613
- Lot / codes
- UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
- Company location
- Lake Forest, IL
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-2312-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-2312-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.