Plum Duo Infusion Pump recall (ICU Medical, Inc.)
Medical deviceClass IIOngoing
Summary: ICU Medical, Inc. is recalling 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.
What is being recalled
Plum Duo Infusion Pump, 40002-0401
Why
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.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
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 named: Idaho, Illinois, Indiana, Kansas, Massachusetts, Maryland, New Mexico, New York, Pennsylvania, Tennessee, Texas)
How to tell if yours is affected
UDI-DI M335400021 Plum Duo Infusion Pump v1.2.3
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-2312-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 29, 2026 |
| Reported | June 17, 2026 |
| Company | ICU Medical, Inc. |
| Company location | Lake Forest, IL, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 13,613 |
More recalls from ICU Medical, Inc. · all medical device recalls · recalls from April 2026