Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1758

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

Medical DeviceNov 23, 2016

ICU Medical TRANSPAC IV DISPOSABLE TRANSDUCER WITH 4 FT recall — FDA Z-0453-2017

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 KIT W/SAFESET" AND 03ML FLUSH DEVICE FOR O.H.S.U., Item No. 46080-38 The recall — FDA Z-0489-2017

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/03 ml Squeeze Flush Device, Arterial Safeset" recall — FDA Z-0559-2017

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 ADD-ON DISP. TRANSDUCER W/03ML FLUSH DEVICE FOR JOHNS HOPKINS HOSP., Item No. recall — FDA Z-0495-2017

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

Alere Triage Total 5 Control Level 1, Model No. 88753 Description of the product: The Triage recall — FDA Z-0588-2017

Encoded with incorrect ranges that are not consistent with the ranges printed on the Expected Value Card.

Class IIFDA: TerminatedAlere San Diego, Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Monitoring Kit, 60", 03 ml Squeeze Flush Device, 2 3 Way Stopcocks recall — FDA Z-0561-2017

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 ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test) recall — FDA Z-0397-2017

Vitamin D Total- Change in Correlation Between Serum and Plasma Specimen Tubes- negative bias with plasma vs. serum samples

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceNov 23, 2016

ICU Medical MONITORING KIT WITH 03ML FLUSH DEVICE FOR CONCORD HOSP., Item No. 46091-13 The recall — FDA Z-0503-2017

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 Q, Angiographic x-ray system Product Usage: The Artis recall — FDA Z-0601-2017

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

Philips Medical Systems (Cleveland) IQon Spectral CT Computed Tomography X-ray system, Model recall — FDA Z-0598-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

ICU Medical TRIPLE MK W/03ML FLUSH DEVICE FOR UNIV OF PENN recall — FDA Z-0497-2017

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

Philips Medical Systems (Cleveland) Brilliance ICT SP Computed Tomography X-ray system recall — FDA Z-0594-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

ICU Medical CATH LAB KIT FOR ALBERT EINSTEIN M.C., Item No. 46047-19 The Transpac Disposable recall — FDA Z-0457-2017

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 RIGHT HEART KIT FOR NC BAPTIST HOSPITAL, Item No. 46066-34 The Transpac recall — FDA Z-0472-2017

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 BAPTIST M recall — FDA Z-0488-2017

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 48", 2 Disposable Transducers, 2 03 ml recall — FDA Z-0416-2017

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/03 ml Squeeze Flush and Macrodrip, Item No. recall — FDA Z-0555-2017

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 #2 FOR MARY HITCHCOCK MEM recall — FDA Z-0460-2017

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 PTCA KIT W/03ML FLUSH DEVICE FOR WILLIAMSPORT HOSP, Item No. 46095-22 The recall — FDA Z-0517-2017

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 WITH 03ML FLUSH DEVICE FOR METHODIST M.C recall — FDA Z-0480-2017

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 M.K. WITH 03ML FLUSH DEVICE FOR DRISCOLL FOUNDATION CHILDRENS HOSP., Item No. recall — FDA Z-0473-2017

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

Philips Medical Systems (Cleveland) Ingenuity Core Computed Tomography X-ray system, Model recall — FDA Z-0597-2017

The product label does not include the correct current rating.

Class IIIFDA: TerminatedPhilips Medical Systems (Cleveland) Inc.

Medical DeviceNov 23, 2016

ICU Medical Transpac IV Trifurcated Monitoring Kit w/84" Safeset" Reservoir, 03 ml Squeeze recall — FDA Z-0565-2017

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

Roche Diagnostics Operations COBAS INTEGRA 800 Tina-Quant Hemoglobin A1cDX Gen.2 Hemoglobin recall — FDA Z-0396-2017

.Roche Diagnostics has confirmed elevated QC and patient sample recovery for individual Tina-quant Hemoglobin A1c Gen.2 and Tina-quant Hemoglobin A1cDx Gen.2 cassettes/bottles. This issue…

Class IIFDA: TerminatedRoche Diagnostics Operations, Inc.

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