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 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY STOPCOCK, Item No. 46098-79 The Transpac Di
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 4 PORT "OFF" MANIFOLD, w/HP STOPCOCK, WASTE BAG ASSY, 10 cc SYRINGE & AD SETS, Item No. 46098-78 The Transpac Disposabl
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/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP & TP4, Item No. 46098-76 The Transpac D
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/3 PORT "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE & TP-4, Item No. 46098The Transpac Disp
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/03 ml Intraflo, 2 Port Manifold Right OFF Rotator and TP4, Item No. 46098-19 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 Cath Lab Kit w/Waste Bag, dyePod¿, Sosa Spike & Syringe, Item No. 46098-11 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 SINGLE (1) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-66 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 (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN. HOSP., Item No. 46097-65 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 TRANSDUCER KIT FOR MEDICAL CTR. AT BOWLING GREEN, Item No. 46097-64 The Transpac Disposable Straight Pressure Transduce
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 MK W/03ML FLUSH DEVICE FOR UNIV. HEALTH SYSTEM, Item No. 46097-62 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 QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. 46097-36 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 PERFUSION KIT W/03ML FLUSH DEVICE FOR NE REGIONAL MED. CTR, Item No. 46097-33 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 SAFESET" KIT W/03ML FLUSH DEVICE FOR HOLMES REG. M.C., Item No. 46097-30 The Transpac Disposable Straight Pressure Tran
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/3 PORT ''ON'' MANIFOLD, WASTE BAG, TP4, SYRINGES & 30 ml BURETTE, Item No. 46096-26 The Transpac Disposa
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, Item No. 46096-25 The Transpac Disposable Straight Pressure Transducer (DSPT) is an extravascular 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 CARDIAC CATH LAB KIT FOR PRESBYTERIAN INTERCOMMUNITY HOSP., Item No. 46095-33 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 PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 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 Cath Lab Kit w/3 Port "ON" Manifold, 03 ml Flush Device, Waste Bag, HPT, Syringe, TP4 and 30 ml Contrast Reservoir, Item
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 Neonate Kit With 30 ml Flush Device For Driscoll Foundation For Children, Item No. 46094-71 The Transpac Disposable Str
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/30 ML FLUSH DEVICE FOR EGLESTON HOSP., Item No. 46094-50 The Transpac Disposable Straight Pressure Tra
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 QUAD KIT WITH THREE TRANSPAC¿ AND 03ML FLUSH DEVICES FOR ST. FRANCIS HOSP., Item No. 46094-47 The Transpac Disposable S
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 NYU MED CTR, Item No. 46094-37 The Transpac Disposable Straight Pressure Tran
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 KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 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 BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The Transpac Disposable Straight Pressure Tra
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 KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. 46094-08 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 PEDIATRIC CVL MONITORING KIT W/03ML FLUSH DEVICE FOR YALE NEW HAVEN HOSP., Item No. 46094-06 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 CATH LAB KIT FOR SALINA REGIONAL, Item No. 46092-34 The Transpac Disposable Straight Pressure Transducer (DSPT) is an e
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 W/03ML FLUSH DEVICE FOR UNIV. OF IOWA, Item No. 46091-56 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 PERFUSION KIT FOR UNIV. OF IOWA, Item No. 46091-51 The Transpac Disposable Straight Pressure Transducer (DSPT) is an ex
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 PRESSURE KIT W/03ML FLUSH DEVICE FOR LEBONHEUR CHILDRENS HOSP., Item No. 46091-31 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.