Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1755

The newest recall records with useful source details are listed here.

Medical DeviceNov 23, 2016

ICU Medical HEART KIT W/03ML FLUSH DEVICE FOR ST recall — FDA Z-0486-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Monitoring Kit w/TP4, 30 ml Squeeze Flush and Needleless Valve, Item No. recall — FDA Z-0438-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Beckman Coulter Access Ostase QC, Catalog No. 37309, B83877 Product Usage: The Access Ostase recall — FDA Z-0408-2017

Beckman Coulter has determined that the Access Ostase Calibrator and Access Ostase QC lots do not meet their expiration date claims within the 10% criteria.

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/4 Way Stopcock, 3 Way Stopcock and 24" Arterial recall — FDA Z-0437-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Siemens Medical Solutions USA AXIOM Artis, Angiographic x-ray system Product Usage: The recall — FDA Z-0603-2017

The possibility exists that the semi-automatic focus switch may not work as intended when pressing the footswitch multiple times.

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceNov 23, 2016

C.R. Bard Bard Inlay Optima Multi-Length Ureteral Stent Coated Double Pigtail Ureteral Stent recall — FDA Z-0405-2017

Labeling: Statement was added to the Warnings/Precautions section requesting end users to consider the presence of a knot if significant resistance is encountered during attempts at removal.

Class IIFDA: TerminatedC.R. Bard, Inc.

Medical DeviceNov 23, 2016

ICU Medical CARDIAC KIT WITH 03 ml FLUSH DEVICE, Item No. 46099-57 The Transpac Disposable recall — FDA Z-0537-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical ICN TRANSDUCER KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV recall — FDA Z-0469-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/Safeset 84" Arterial Pressure Tubing, Reservoir recall — FDA Z-0553-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Cath Lab Kit w/Waste Bag System, 3 Port "OFF" Manifold (600 psi), Transpac IV recall — FDA Z-0540-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORT, 60" recall — FDA Z-0446-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH recall — FDA Z-0415-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/Safeset" Blood Sampling Port and 03 ml Squeeze recall — FDA Z-0558-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TP4 Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze Flush and Needleless recall — FDA Z-0542-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT, 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH recall — FDA Z-0431-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical LEFT HEART KIT FOR PORTLAND ADVENTIST HOSP., Item No. 46066-13 The Transpac recall — FDA Z-0471-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV BIFURCATED KIT WITH SAFESET" RESERVOIR AND BLOOD SAMPLING PORTS, 84" recall — FDA Z-0420-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

Siemens Medical Solutions USA SOMATOM Definition AS, Computed tomography x-ray system The recall — FDA Z-0606-2017

Siemens is releasing a software update that provides bug-fixes to improve system performance for customers with SOMATOM Definition AS, SOMATOM Definition Edge, SOMATOM Definition Flash…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV BIFURCATED MONITORING KIT 72 INCH, 2 DISPOSABLE TRANSDUCER, 2 3 ML recall — FDA Z-0450-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRIPLE PRESSURE KIT W/03ML FLUSH DEVICE FOR UNIV recall — FDA Z-0506-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit w/Arterial 84" Safeset" Reservoir, 03 ml Squeeze recall — FDA Z-0562-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical CATH LAB KIT WITH 03ML FLUSH DEVICE FOR CARLE CLINIC, Item No. 46087-37 The recall — FDA Z-0496-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV MONITORING KIT WITH DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH AND recall — FDA Z-0439-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac w/Safeset Reservoir, Squeeze 03 ml Flush and Needleless Valve, Item No. recall — FDA Z-0544-2017

ICU Medical Inc. has identified a potential for leak with certain SafeSet Reservoir and blood sampling kits containing the Transpac IV transducers.

Class IIFDA: TerminatedICU Medical, Inc.

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