ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
The Plum Duo Infusion Pump may fail to display alerts when medication delivery limits are exceeded. Without these warnings, clinicians may not know before the pump starts delivering the wrong amount of medication to a patient.
From the FDA notice · Read the official notice ↗ · All ICU Medical recalls
What to do
- If your facility uses this pump model (40002-0401), contact ICU Medical for guidance on checking your device.
- Check with your biomedical or clinical engineering team for any facility-level updates or patches.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Plum Duo Infusion Pump, 40002-0401
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 13,613
- Illnesses reported
- None reported
- Manufactured in
- 600 N Field Dr, N/A, Lake Forest, IL, United States
- Classification
- Class II
- Recall number
- Z-2312-2026
In the FDA's words
- Description
- Plum Duo Infusion Pump, 40002-0401 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. 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. Affected quantity: 13,613
- Hazard
- 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.
3 products in this recall
ICU Medical Plum infusion pumps recalled for missed dosing alerts
ICU Medical is recalling three Plum infusion pump models, covering 13,613 units each. Under certain conditions, the pump may not show a soft limit alert or warn the clinician of a soft limit violation before delivery starts, which could lead to under- or over-delivery of medication. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- Plum Solo Precision IV Pump, 40001-0401Z-2311-2026 · 13,613
- Plum Duo Infusion Pump, 40002-0401 (this page)Z-2312-2026 · 13,613
- Plum Duo Precision IV Pump, 40002-0403Z-2313-2026 · 13,613
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ModerateFDASep 23, 2026