Latest U.S. Recalls — FDA & NHTSA Records

Latest records

Latest recalls — page 1753

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

Medical DeviceNov 30, 2016

Merit Medical Systems Custom Fluid Management Set, Sterile, EO, Rx Only Used to transfer recall — FDA Z-0649-2017

Merit Medical Systems, Inc. announces a voluntary field action for Fluid Administration Sets due to a molding defect in the drip chamber.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm recall — FDA Z-0625-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm Item recall — FDA Z-0628-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Toshiba American Medical Systems Aquilion Prime TSX-303A Aquilion PRIME is a multislice recall — FDA Z-0622-2017

Toshiba American Medical Systems (TAMS) is recalling the Aquilion CT system because it has been reported that the cooling oil in the x-ray tube heat exchanger may leak during system…

Class IIFDA: TerminatedToshiba American Medical Systems Inc.

Medical DeviceNov 30, 2016

Merit Medical Systems Fluid Management Set recall — FDA Z-0631-2017

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

Bausch & Lomb Inc Irb PeroxiClear Peroxide Solution recall — FDA Z-0651-2017

Product was found to contain excess residual levels of hydrogen peroxide.

Class IIFDA: TerminatedBausch & Lomb Inc Irb

Medical DeviceNov 30, 2016

Philips Healthcare System X-ray Tomography Computed recall — FDA Z-0375-2017

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm recall — FDA Z-0630-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm recall — FDA Z-0624-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Merit Medical Systems Waste Management Kit recall — FDA Z-0633-2017

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm recall — FDA Z-0626-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Merit Medical Systems Procedure Kit. Catalog Numbers K12-04830B and K12-YP030A recall — FDA Z-0635-2017

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

Pentax Video Colonoscope is intended to be used with a PENTAX video processor recall — FDA Z-0636-2017

Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they…

Class IIFDA: TerminatedPentax of America Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm recall — FDA Z-0629-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Diasorin LIAISON Estradiol II Gen, 310680, 310680-CN The DiaSorin LIAISON Estradiol II Gen recall — FDA Z-0645-2017

DiaSorin is issuing an urgent medical device correction for the LIAISON Estradiol II Gen assay. Due to the risk of a recently identified cross reactivity, the LIAISON Estradiol II Gena…

Class IIFDA: TerminatedDiasorin Inc.

Medical DeviceNov 30, 2016

Beckman Coulter AQUIOS Lyse Reagent Kit, Catalog No recall — FDA Z-0648-2017

Beckman Coulter is recalling the AQUIOS Lyse Reagent Kit because it may lead to an increased generation of notifications and flags when used on the AQUIOS CL when running the AQUIOS Tetra…

Class IIFDA: TerminatedBeckman Coulter Inc.

Medical DeviceNov 30, 2016

AtriCure COBRA Fusion 50 Ablation System, COBRA Fusion 150 Ablation System, and COBRA Fusion recall — FDA Z-0653-2017

Due to product design and process control, part of the device can separate and remain behind when the device is removed that can potentially cause permanent impairment or damage to body…

Class IIFDA: TerminatedAtriCure, Inc.

Medical DeviceNov 30, 2016

Siemens Healthcare Diagnostics Dimension Vista Chemistry 1 Calibrator The Chemistry 1 recall — FDA Z-0652-2017

Siemens determined that discrepant low calcium recovery of QC and patient samples can occur with Dimension Vista CHEM 1 CAL lots 5GM081 and 5GM082.

Class IIFDA: TerminatedSiemens Healthcare Diagnostics, Inc.

Medical DeviceNov 30, 2016

Philips Healthcare System X-ray Tomography Computed recall — FDA Z-0376-2017

It was discovered the patient support tabletop may fail to move in the horizontal direction when it is commanded to do so during CT scans due to a potential mechanical linkage failure.

Class IIFDA: TerminatedPhilips Electronics North America Corporation

Medical DeviceNov 30, 2016

Merge RadSuite,f/k/a: Emageon Advanced Visualization , RadSuite versions 8.30.7.8, 8.30.7.9 recall — FDA Z-0614-2017

It was reported by a customer that RadSuite images are not appearing as readable images. This product malfunction has the potential to result in delay in care and a possible re-exposure of…

Class IIFDA: TerminatedMerge Healthcare, Inc.

Medical DeviceNov 30, 2016

Merit Medical Systems Pressure Monitoring Kit (MeriTrans") recall — FDA Z-0634-2017

Merit Medical Systems, Inc. announces a voluntary field action for various Merit Medical Procedure Kits due to a compromised sterile barrier.

Class IIFDA: TerminatedMerit Medical Systems, Inc.

Medical DeviceNov 30, 2016

DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm recall — FDA Z-0627-2017

SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Class IIFDA: TerminatedDePuy Spine, Inc.

Medical DeviceNov 30, 2016

Greatbatch Stiffer Coaxial Micro-Introducer recall — FDA Z-0623-2017

Greatbatch Medical has identified an issue with the Stiffer Coaxial Micro-Introducer 4FR and 5FR after a field complaint reported that the rotating luer detached from the dilator hub during…

Class IIFDA: TerminatedGreatbatch Medical

FoodNov 30, 2016

JML Holdings Three Way Popcorn Sampler that contains three types of popcorn recall — FDA F-0503-2017

Undeclared eggs on the finished product label.

Class IFDA: TerminatedJML Holdings Inc.

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