FDA-Device2026-06-17Class IIPROCESSING DEFECT
ICU Medical Plum Duo Precision IV Pump recalled for missing soft limit alerts
OTHERNationwide distribution
ICU Medical Plum Duo IV Pump recalled for alert display failure
The Plum Duo Precision IV Pump may fail to display a soft limit alert under certain conditions, meaning clinicians won't be notified before the pump starts delivering medication that exceeds the set safety limit. This could result in patients receiving too much or too little medication.
- If you operate this pump (model 40002-0403, v1.2.3), contact ICU Medical for guidance or a firmware update.
- Review your facility's inventory and alert procedures for affected units.
- Monitor infusions more closely on affected pumps until you receive official corrective instructions from ICU Medical.
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.
Sold states
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 count
13,613
Manufactured in
600 N Field Dr, N/A, Lake Forest, IL, United States
Products
Plum Duo Precision IV Pump, 40002-0403
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2313-2026More ICU Medical, Inc. recalls
- FDA-Device2026-06-17ICU Medical Plum Duo Infusion Pump recalled for missing soft limit alerts
- FDA-Device2026-06-17ICU Medical Plum Solo Precision IV Pump recalled for missed soft limit alerts
- FDA-Device2026-05-27ICU Medical ChemoLock oncology infusion sets recalled for potential leakage during therapy
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