Class II

Medical Device Recall: Plum Solo Precision IV Pump, 40001-0401

ICU Medical, Inc. · April 29, 2026

Reason for Recall

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.

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.

States Affected

NATIONWIDE

Quantity Affected

13,613

Source: FDA (openFDA Device Enforcement)

Recall number: Z-2311-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ICU Medical, Inc. Medical Device Recall: Plum Solo Precision IV Pump, 40001-0401 | SafeCheck