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Medical Device Recalls in the United States

Monitor U.S. medical device recall enforcement reports from the FDA. Review product descriptions, recall reasons, classifications, dates, recalling firms and distribution information where the FDA provides them.

28,535medical device recall records

2,363FDA Class I records

8firms with 5+ records

Zimmer Biomet, Inc.784 records

Database records

Records — page 1007

28,535 detailed records are currently available in this category.

Medical DeviceDec 7, 2016

Teleflex Medical ARROW OnControl Bone Marrow Biopsy System Comprehensive Tray, Sterile, The recall — FDA Z-0676-2017

Sterility: Due to a potential incomplete seal on the outer sterile package.

Class IIFDA: TerminatedTeleflex Medical

Medical DeviceDec 7, 2016

Baxter Healthcare sigma spectrum VOLUMETRIC INFUSION PUMP with Master Drug Library, V6 recall — FDA Z-0670-2017

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that…

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceDec 7, 2016

MicroPort Orthopedics Lineage Shell: REF 36693646, REF 36693848, REF 36694050, REF 36694252 recall — FDA Z-0686-2017

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and…

Class IIIFDA: TerminatedMicroPort Orthopedics Inc.

Medical DeviceDec 7, 2016

Baxter SIGMA Spectrum INFUSION PUMP with Master Drug Library, V8 Spectrum Infusion Pump recall — FDA Z-0671-2017

A correction was issued for the SIGMA Spectrum Infusion Pump with Master Drug Library in order to replace speakers installed in pumps or included in spare part rear case assemblies that…

Class IIFDA: TerminatedBaxter Healthcare Corp.

Medical DeviceDec 7, 2016

Spectranetics ELCA Coronary Atherectomy Catheter recall — FDA Z-0662-2017

Spectranetics Corporation announces a voluntary field action for the Turbo Elite Atherectomy Catheter, ELCA Coronary Atherectomy Catheter, and Bridge Occlusion Balloon due to potentially…

Class IIFDA: TerminatedSpectranetics Corporation

Medical DeviceDec 7, 2016

MicroPort Orthopedics Lineage Liners: REF 70102846, REF 70202852, REF 70202852, REF recall — FDA Z-0683-2017

Revision rate trends from within the MicroPort Orthopedics Inc. database evaluated for the modular head Metal on Metal THA systems show an increasing overall trend from 2009 to present and…

Class IIIFDA: TerminatedMicroPort Orthopedics Inc.

Medical DeviceDec 7, 2016

Sorin Group USA ST¿CKERT HeaterCooler System 3T recall — FDA Z-0682-2017

On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for…

Class IIFDA: TerminatedSorin Group USA, Inc.

Medical DeviceDec 7, 2016

Teleflex Medical ARROW OnControl Ported Aspiration System Tray, Sterile, Rx only, The Arrow recall — FDA Z-0679-2017

Sterility: Due to a potential incomplete seal on the outer sterile package.

Class IIFDA: TerminatedTeleflex Medical

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

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

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

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

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

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

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

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

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

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

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

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

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 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-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

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.

How to use this medical device recall index

Medical device recall records can change as the FDA receives additional information. Check the official record identifier and current FDA information before making health or product-use decisions.

Recall Lookup USA keeps the last complete source record available when an official data service is temporarily unavailable. When a source provides only a few fields, we show only those known facts rather than padding the page with generic text.

What the database can and cannot tell you

This database is designed for discovery and reference. It can help you locate a relevant recall record, identify the recalling firm or NHTSA campaign, compare dates and classifications, and follow the official source. It is not a substitute for a VIN-specific NHTSA check, a manufacturer notice, medical advice or instructions issued by the recalling company.