ICU Medical, Inc.
ICU Medical, Inc.: 11 recalls listed since January 2026 across FDA.
By year
- 202611
By agency
- FDA11
By category
- Medical Device11
All recalls (11)
CADD Yellow Medication Cassette Reservoir with NRFit Connector
Reservoirs may exhibit medication leakage at the joint between luer connector and tubing.
ICU Medical IV and Oncology Administration Sets
Intravascular administration tubing sets may have black specks in drip chambers.
8 products
ICU Medical IV Sets with Drip Chambers
IV Sets with drip chambers may have black specks which could result in a delay in therapy.
Hotline Fluid Warming Set
The Hotline Fluid Warming Set may have an increased likelihood of leakage in specific lots.
ICU Medical Plum Duo Infusion and Solo Precision IV Pump
The Plum Duo Infusion Pump may deliver up to twice the programmed volume in a specific scenario.
2 products
Plum Duo Infusion, Duo Precision IV, and Solo Precision IV Pump
The Plum Solo Precision IV Pump may not display a soft limit alert, potentially leading to under- or over-delivery.
3 productsICU Medical ChemoLock Oncology Kits and Transfer Sets
Oncology sets may leak, causing therapy interruption and possible exposure to hazardous substances.
ICU Medical Plum Duo and Plum Solo Infusion Pumps
ICU Medical Plum Duo and Plum Solo Infusion Pumps can prevent programming a piggyback flush, causing a violation message.
3 products
ICU Medical Tego Connector
The Tego Connector has a silicone seal that may bulge, separate, or tear, causing fluid leaks and therapy interruption.
ICU Medical Plum Duo Infusion System
The Plum Duo Infusion System may fail to produce audible alarms, alerts, or feedback for touchscreen inputs.
ICU Medical Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray
Pulsator Arterial Blood Sampling Kit and Portex Spinal Tray may have cracked syringe collars, leading to delayed or repeated blood draw or fluid leakage.
2 products