Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1757

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

Medical DeviceNov 23, 2016

ICU Medical 4 Port "ON" Manifold (600 psi) w/4 ft recall — FDA Z-0572-2017

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 2 BLOOD SAMPLING PORTS recall — FDA Z-0451-2017

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

Stryker Instruments Div. of Stryker RF MultiGen, 0406-900-000 recall — FDA Z-0584-2017

Stryker Instruments is voluntarily recalling the Care Instructions/Instructions for Use packaged with the Radiofrequency (RF) MultiGen Generator, because the instructions for use…

Class IIIFDA: TerminatedStryker Instruments Div. of Stryker Corporation

Medical DeviceNov 23, 2016

ICU Medical 4 Port "ON" Manifold (600 psi) w/4 ft recall — FDA Z-0414-2017

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 Artis zee/zeego, Angiographic x-ray system Product Usage: The recall — FDA Z-0602-2017

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

Roche Diabetes Care Version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS) recall — FDA Z-0586-2017

Roche Diabetes Care, Inc. initiated a voluntary recall for the version 1.2.0 of Accu-Chek Connect Diabetes Management App (iOS), released on July 11, 2016, due to the software containing a…

Class IIFDA: TerminatedRoche Diabetes Care, Inc.

Medical DeviceNov 23, 2016

Atrium Medical 10 Fr Trocar catheter, Sterile recall — FDA Z-0577-2017

Trocar Catheters are packaged with a label containing an icon that shows more holes (eyelets) than the product actually contains.

Class IIFDA: TerminatedAtrium Medical Corporation

Medical DeviceNov 23, 2016

ICU Medical Cath Lab Left Heart Kit w/3 Port Manifold "OFF" (600 psi), Transpac IV, Waste recall — FDA Z-0571-2017

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 Disposable Transducer w/Stopcocks w/o Cap and Covers, Item No. recall — FDA Z-0563-2017

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 NEONATAL KIT WITH 30ML FLUSH DEVICE FOR YALE-NEW HAVEN HOSP., Item No. 46068-65 recall — FDA Z-0476-2017

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 Kit W/03ML Flush Device, Mounts, Reservoir & TP4, Item No. 46099-24 The recall — FDA Z-0536-2017

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 2 BONDED STOPCOCKS, 72", DISPOSABLE TRANSDUCER recall — FDA Z-0418-2017

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/4 Way Stopcock, 3 Way Stopcock and 24" Arterial recall — FDA Z-0436-2017

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 WITH 03ML FLUSH DEVICE FOR UNIVERSITY OF MICHIGAN HOSP., Item recall — FDA Z-0463-2017

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 DISPOSABLE TRANSDUCER WITH STOPCOCKS AND WITHOUT COVERS, Item No. recall — FDA Z-0454-2017

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 "OFF" MANIFOLD, WASTE BAG, GUIDE WIRE, SPLASH STOP, NEEDLE recall — FDA Z-0530-2017

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 ANESTHESIA KIT W/03ML FLUSH DEVICE FOR JACKSON MEM recall — FDA Z-0468-2017

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 DISPOSABLE TRANSDUCER MONITORING KIT WITH BONDED STOPCOCK AND 3mL recall — FDA Z-0425-2017

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

Bayer Healthcare PET Infusion Pump recall — FDA Z-0400-2017

The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one…

Class IIFDA: TerminatedBayer Healthcare

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV TRIFURCATED MONITORING KIT, 84" 3 DISPOSABLE TRANSDUCERS WITH 2 recall — FDA Z-0435-2017

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 KIT W/03ML FLUSH DEVICE FOR DUKE UNIVERSITY, Item No. 46094-21 The recall — FDA Z-0511-2017

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, Item No recall — FDA Z-0575-2017

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 MONITORING KIT, 72" 2 DISPOSABLE TRANSDUCERS, with 2 recall — FDA Z-0421-2017

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-0445-2017

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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