FDAFDA · Food and drugs·Recall number Z-2311-2026
Plum Solo Precision IV Pump, 40001-0401
Published June 17, 2026 · Recall initiated: April 29, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- ICU Medical, Inc.
- Distributor
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- Lot
- UDI-DI M335400011 Plum Solo Precision IV Pump v1.0.3
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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