Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1762

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

Medical DeviceNov 23, 2016

MEVION S250 Product Usage: Proton Radiation Therapy System recall — FDA Z-0411-2017

Software defect:2D projection of contours in Verity. The defect causes structures to appear off from their true position in the DRR and the radiograph with an error that increases with the…

Class IIFDA: TerminatedMevion Medical Systems, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit, 60", Disposable Transducer, 30 ML Intraflo Flush recall — FDA Z-0552-2017

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 Healthcare Diagnostics ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the recall — FDA Z-0612-2017

CA 19-9 assay on the ADVIA Centaur CP does not meet the correlation to the CA 19-9 assay on the ADVIA Centaur/XP/XPT systems as stated in the Instructions for Use.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceNov 23, 2016

ICU Medical OPEN HEART KIT W/03ML FLUSH DEVICE FOR CUMBERLAND COUNTY HOSP., Item No. recall — FDA Z-0509-2017

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 ARTERIAL SET-UP W/03ML FLUSH DEVICE FOR ORLANDO REG recall — FDA Z-0475-2017

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 SQUEEZE FLUSH recall — FDA Z-0549-2017

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 Flash, Computed tomography system Product recall — FDA Z-0605-2017

A problem can occur with the small light marker windows, used for the positioning laser and are integrated in the front cover of the SOMATOM Definition AS and Definition Flash systems, by…

Class IIFDA: TerminatedSiemens Medical Solutions USA, Inc.

Medical DeviceNov 23, 2016

ICU Medical QUAD KIT WITH THREE TRANSPAC AND 03ML FLUSH DEVICES FOR ST recall — FDA Z-0513-2017

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/4 PORT "ON" MANIFOLD, WASTE BAG, SYRINGE, WASTE BASIN, SHARPSTOP recall — FDA Z-0531-2017

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 PERFUSION KIT FOR UNIV recall — FDA Z-0505-2017

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

Merge Healthcare iConnect Access software recall — FDA Z-0611-2017

Software displayed incorrect prior reports in the viewport area, only when more than one prior study (2 or more) was viewed.

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceNov 23, 2016

Siemens Medical Solutions USA SOMATOM Definition Edge, Computed tomography x-ray system The recall — FDA Z-0607-2017

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 MONITORING KIT , 60", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH recall — FDA Z-0441-2017

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 #3 w/03 ml Flush Device for Childrens Hosp, Item No. 46010-34 The recall — FDA Z-0455-2017

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 TRANSDUCER KIT FOR MEDICAL CTR recall — FDA Z-0525-2017

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 BIFURCATED KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-20 The recall — FDA Z-0510-2017

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, 9", DISPOSABLE TRANSDUCER, 3 ML INTRAFLO FLUSH recall — FDA Z-0433-2017

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/3 Port "ON" Manifold (600 psi), Transpac IV, 2 Admin Sets and 8 recall — FDA Z-0570-2017

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 ART LINE KIT W/ 3ML FLUSH DEVICE FOR JACKSON MEM recall — FDA Z-0458-2017

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 (3) DISPOSABLE TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUTHERAN GEN recall — FDA Z-0526-2017

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 Flash, Computed tomography x-ray system The recall — FDA Z-0608-2017

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