ICU Medical, Inc. Recalls

6 recalls on record in the United States

medical: 6
medical Class II
2026-05-27

ICU Medical, Inc. recalls Oncology Kit w/60" (152 cm) Appx 2.2 ml, Smallbore Ext Set w

Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential for the patient to receive less infusion solution than intended. Exposure of hazardous substances to the patient, caregiver, or pharmacy technician is possible.

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medical Class II
2026-06-17

ICU Medical, Inc. recalls Plum Duo Precision IV Pump, 40002-0403

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.

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medical Class II
2026-06-17

ICU Medical, Inc. recalls 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.

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medical Class II
2026-06-17

ICU Medical, Inc. recalls Plum Solo Precision IV Pump, 40001-0401

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.

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medical Class II
2026-07-22

ICU Medical, Inc. recalls ICU Medical Plum Duo Infusion Pump, v1.2.3: 1) Item Number

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

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medical Class II
2026-07-22

ICU Medical, Inc. recalls ICU Medical Plum Solo Precision IV Pump, v1.0.3, Item Number

In a specific scenario, the pump will not decrement the Volume to be Infused (VTBI) displayed on the Delivery screen and may deliver up to twice the VTBI at the programmed rate.

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