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ICU Medical Recalls

657 recalls on record · August 8, 2012 to July 29, 2026 · Drugs, Medical Devices

Recalls by year

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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.

November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The Transpac Disposable Straight Pressure Tr
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CVP ARTERIAL LINE KIT WITH 03ML FLUSH DEVICE FOR KANSAS HEART HOSP, Item No. 46091-04 The Transpac Disposable Straight
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Cath Lab Kit W/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 The Transpac Disposable Straight Pressu
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 The Transpac Disposable Straight Pressur
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CATH LAB KIT FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable Straight Pressure Transducer (DSPT) is
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRIFURCATED DISPOSABLE TRANSDUCER KIT W/03ML FLUSH DEVICE FOR JOHNS HOPKINS/BAYVIEW, Item No. 46088-74 The Transpac Dis
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN. HEALTH SYSTEMS, Item No. 46088-08 The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The Transpac Disposable Straight Pressure Trans
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. 46086-21 The Transpac Disposable Straight
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRIFURCATED DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP, Item No. 46086-20 The Transpac Disposable Stra
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls MONITORING KIT WITH 03ML FLUSH DEVICE FOR UNIV. OF NEW MEXICO, Item No. 46085-50 The Transpac Disposable Straight Press
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls MONITORING KIT WITH 03ML FLUSH DEVICE FOR LEHIGH VALLEY HOSPITAL CENTER, Item No. 46085-47 The Transpac Disposable Stra
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High Pressure Manifold and Transpac¿ IV Disposable
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls MONITORING KIT W/03ML FLUSH DEVICE FOR MEDICAL COLLEGE OF GA, Item No. 46080-51 The Transpac Disposable Straight Pressu
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRIPLE KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The Transpac Disposable Straight Pressure T
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CATH LAB KIT FOR BAPTIST M. C., Item No. 46078-52 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Cath Lab Kit For Elkhart Hosp., Item No. 46078-17 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ext
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls HEART KIT W/03ML FLUSH DEVICE FOR ST. JOSEPHS HOSP., Item No. 46076-59 The Transpac Disposable Straight Pressure Transd
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-26 The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls SINGLE LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. 46076-25 The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR ALL CHILDRENS HOSP., Item No. 46076-21 The Transpac Disposable Straight Press
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls MONITORING KIT W/03ML FLUSH DEVICE FOR PITT CO. MEM. HOSP., Item No. 46076-19 The Transpac Disposable Straight Pressure
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls CARDIAC CATHETERIZATION WASTE MANAGEMENT SYSTEM LEFT HEART KIT, Item No. 46073-14 The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls TRIPLE PRESSURE KIT WITH 03ML FLUSH DEVICE FOR METHODIST M.C. OF ILLINOIS, Item No. 46072-51 The Transpac Disposable St
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls RIGHT HEART CATH LAB KIT FOR BAPTIST MEM. HOSP., Item No. 46071-40 The Transpac Disposable Straight Pressure Transducer
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls PERFUSION PUMP KIT FOR MEMORIAL HOSP., Item No. 46070-79 The Transpac Disposable Straight Pressure Transducer (DSPT) is
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls KIT W/30ML FLUSH DEVICE FOR ALL CHILDRENS Hospital, Item No. 46070-30 The Transpac Disposable Straight Pressure Transdu
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 The Transpac Disposable Straight Pressu
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-49 The Transpac Disposable Straight Pres
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.
November 23, 2016Medical DevicesFDA
ICU Medical, Inc. recalls OPEN HEART MONITORING KIT WITH 03ML FLUSH DEVICE FOR ORLANDO REG. MED. CTR., Item No. 46068-48 The Transpac Disposable
Hazard: ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.