Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1761

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

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Trifurcated Monitoring Kit 84" w/03 ml Squeeze Flush Device, Red recall — FDA Z-0566-2017

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 FOR GENESIS HEALTH CARE, Item No. 46089-74 The Transpac Disposable recall — FDA Z-0499-2017

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 2 PORT RIGHT "OFF" MANIFOLD w/ADMIN SET 72" PT, 3 WAY STOPCOCK, TP4 & 1 WAY recall — FDA Z-0533-2017

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 Cardiac Catheterization Right Heart Kit w/2-Station, Right Hand, On, High recall — FDA Z-0491-2017

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, 72", DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH recall — FDA Z-0443-2017

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 WITH 03ML FLUSH DEVICE FOR NYU MED CTR, Item No. 46094-37 The recall — FDA Z-0512-2017

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

Trilliant Surgical Model 208-70-110, Long Thread Tiger Large Cannulated Headless Screw, 7 x recall — FDA Z-0609-2017

Screws were identified as having the incorrect part number and lot number marked upon them. The part number incorrectly indicated a length of 115 mm rather than 110 mm. The lot number…

Class IIFDA: TerminatedTrilliant Surgical Ltd.

Medical DeviceNov 23, 2016

ICU Medical CATH LAB KIT WITH 03ML FLUSH DEVICE FOR MEMORIAL HEALTHCARE, Item No. 46090-07 recall — FDA Z-0500-2017

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 (250 test kit)-for use,with the recall — FDA Z-0613-2017

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 PEDIATRIC ARTERIAL KIT W/30ML FLUSH DEVICE FOR STANFORD UNIV recall — FDA Z-0470-2017

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 DOUBLE LINE KIT W/03ML FLUSH DEVICE & SAFESET, Item No. 46099-18 The Transpac recall — FDA Z-0535-2017

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, 03 ml Flush Device, Waste Bag, HPT recall — FDA Z-0516-2017

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 Calibrators, Catalog No. 37305, B83876 Product Usage: The recall — FDA Z-0407-2017

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 Bifurcated Transpac IV Monitoring Kit w/03 ml Squeeze Flush Device, Red and Blue recall — FDA Z-0556-2017

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 Trifurcated Transpac IV w/03 ml Squeeze Flush Device, 130" Safeset" Reservoir recall — FDA Z-0557-2017

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/30ML Flush Device for Monongalia General Hosp, Item No. 46090-62 recall — FDA Z-0501-2017

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 WITH BONDED STOPCOCK, 3 ML recall — FDA Z-0428-2017

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 QUAD TRANSDUCER KIT WITH 03ML FLUSH DEVICE FOR LUBBOCK HEART HOSP., Item No. recall — FDA Z-0523-2017

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 Double LINE SAFESET" KIT WITH 03ML FLUSH DEVICE FOR E.U.S.H.C., Item No. recall — FDA Z-0485-2017

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, MACRODRIP recall — FDA Z-0426-2017

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 Chemistry Calibrator For in vitro diagnostic use in the recall — FDA Z-0589-2017

Siemens has confirmed that the DBIL_2 Assigned Calibrator Values (ACV) currently assigned to the affected lots may cause, on average, a positive proportional bias of approximately 41% on…

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceNov 23, 2016