- Recalling firm
- ICU Medical, Inc.
- 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 pattern
- Worldwide - US Nationwide distribution in the states of ID, IL, IN, KS, MA, MD, NM, NY, PA, TN, TX and the country of Canada.
- State
- IL
- Status
- Ongoing
- Recall number
- Z-2312-2026
- Recall initiated
- April 29, 2026