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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

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Browse Device Recalls

806 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 806 FDA medical device recall enforcement actions. Each entry includes the device description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Medical Device Recalls

Browse 806 FDA device recalls.

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DateProductReasonClassFirm
Nov 26, 2014 SoftPath Laboratory Information System. Versions 4.3.0.8, 4.3.0.9, 4.3.0.10,... Modifications to diagnostic text may be: 1) Saved to the database but not appear on the report se... Class II SCC Soft Computer
Nov 21, 2014 HemosIL PT-Fibrinogen HS PLUS, IVD --- Instrumentation Laboratory IL Company.... Some vials of HemosIL PT-Fibrinogen HS PLUS, Part No. 0008469810 (various lots manufactured prio... Class II Instrumentation Laboratory Co.
Nov 21, 2014 Cryogenic probe for cardiac ablation surgery, packaged individually in Tyvek ... Affected product may have compromised sterility due to packaging defects. It was determined that ... Class II Atricure Inc
Oct 23, 2014 Oxoid Legionella Pneumo Groups 2-14 Latex Test, DR0802M, containing 50 tests ... A reagent within the test may return false negative results. Class II Remel Inc
Oct 8, 2014 Edwards Lifesciences Vent Catheters, . Packaged sterile and non-pyrogenic in ... Edwards Lifesciences is conducting a field action on the Vent Catheters due to the potential for ... Class II Edwards Lifesciences, LLC
Sep 24, 2014 Foot Switches used with the following systems: Philips Allura Xper Systems; 7... Loss of key image functionality due to a bent pedal of the Footswitch. Class II Philips Medical Systems, Inc.
Sep 16, 2014 Baxter 2B8011 Empty INTRA VIA Container with PVC Ports, Sterile fluid path, ... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Sep 16, 2014 Baxter 2B8013 Empty INTRA VIA Container with PVC Ports (Sterile, nonpyrogen... Particulate matter found inside the fluid path. Class I Baxter Healthcare Corp
Aug 15, 2014 Array LaserLink, Manufactured by Lumenis, The Array" LaserLink" is a laser... Lumenis initiated a field-correction for the Array Laser Link", GA-0006700 (SN XXYYZZ) becau... Class II Lumenis, Inc.
Aug 13, 2014 JBAIDS Instrument System Software version 3.5.0.72. The JBAIDS instrument ... BioFire Defense, LLC is initiating a field action for JBAIDS Software version 3.5.0.72 because th... Class III Biofire Defense
Aug 12, 2014 The Symbia Intevo Excel is a non-diagnostic SPECT ICT system with CT support ... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 The Siemens Symbia T series is intended for use by appropriately trained heal... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Aug 12, 2014 The Siemens Symbia S series is intended for use by appropriately trained heal... Siemens Medical Solutions USA, Inc. has received reports of unintended radial motion of the detec... Class II Siemens Medical Solutions USA, Inc.
Jul 31, 2014 CareFusion AirLife Heated Infant Breathing Circuit Product Usage: Respira... The CareFusion AirLife Heated Infant Breathing Circuit is being recalled due to a regulatory comp... Class II Carefusion 2200 Inc
Jul 14, 2014 ***Baxter***BURETROL Solution Set***105" (2.7 m) 150 mL Burette***Drip Chamb... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 14, 2014 ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jul 14, 2014 ***Baxter***Buretrol Solution Set***105" (2.7 m)***150 mL Burette***Drip Cham... Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solut... Class II Baxter Healthcare Corp
Jun 6, 2014 TrypticaseTM Soy Agar with 5% Sheep Blood (TSA IITM) // MacConkey II Agar ... A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-st... Class II Becton Dickinson & Co.
Jun 5, 2014 Excelsior Medical Sterile Triple Lead Tubing Set and Sterile Heavy Duty Tripl... There is a potential for a leak. A molding defect in the connector that joins the three leads t... Class II Excelsior Medical Corp
May 20, 2014 LAPAROSCOPY PACK - ( 1) APPLIER MULTI CLIP WITH SHAF GUN L/F ( 1) NEEDLE U... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 Chole Cystectomy All Endo System , code 900-3025, contains: (1) TABLE COVER ... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY CHOLE PACK - (6) TOWELS ABSORBENT 15" X 20" LIF (1) MAYO STAND... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 20, 2014 LAPAROSCOPY CHOLE PACK - (4) DRAPE UTILITY WITH TAPE LIF (2) ABSORBENT TOW... Customed has determined that there is the possibility that packaging integrity may be compromised... Class I Customed, Inc
May 8, 2014 MACROLYTE Premie Dispersive Electrode, REF 440-2400, CONMED CORPORATION. Th... ConMed Corporation has received complaints regarding sparking, no output and burning at the cord ... Class II ConMed Corporation
Apr 30, 2014 PATH(R) THREAD CUP ADAPTOR, REF 2007-0013, Wright Medical Technology, Inc. Or... Difficulty removing the cup adaptor from the impaction handle during surgery Class II Microport Orthopedics INC.
Apr 28, 2014 Baxter MiniCap Extended Life PD Transfer Set with Twist Clamp - Extra Short. ... Connection issues between the PD transfer set catheter connector and an adapter may lead to leaks... Class II Baxter Healthcare Corporation
Apr 18, 2014 Thyroglobulin (1D4) is a mouse anti-human monoclonal antibody produced as a t... Bond Ready to Use Primary Antibody Thyroglobulin does not function as intended up to the expiry d... Class II Leica Microsystems, Inc.
Apr 3, 2014 iLab Ultrasound Imaging System; iLab 3.0 (Polaris 1.0) software. Used for ul... Specific iLab Ultrasound Imaging Systems using newest 3.0 (Polaris 1.0) software change the pullb... Class II Boston Scientific Corporation
Mar 7, 2014 Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc... One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp whi... Class II Clarity Medical Systems Inc
Mar 3, 2014 Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length S... Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... Class II Biocardia, Inc.
Mar 3, 2014 Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: ... Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable I... Class II Biocardia, Inc.
Feb 14, 2014 GE Healthcare Optima CT580/Discovery CT590RT scanners running software versio... GE Healthcare has recently become aware of a potential safety issue due to a software issue assoc... Class II GE Healthcare, LLC
Feb 7, 2014 HER2 Image Analysis Manual Read of HER2 Digital Slides ER/PR Image Analysis... In an abundance of caution, Aperio (now known as Lecia Biosystems) is providing additional inform... Class II Leica Biosystems Imaging, Inc.
Feb 7, 2014 MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: ... Tyvek packaging may be worn, causing loss of package integrity. Class II Biocardia, Inc.
Jan 21, 2014 Product Name: HER2 CISH pharmDx Kit Catalog/Model number: SK109, lot 2000091... Dako has initiated a recall of HER2 CISH pharmDxTM Kit because weak red signals have been observed. Class II Dako North America Inc.
Dec 20, 2013 Compensator Slider Lambda 6x20 component (part number 473704-0000-000) utiliz... Carl Zeiss Microscopy, LLC has recalled the Compensator Slider Lamda 6x20 component utilized on S... Class II Zeiss, Carl Inc
Dec 6, 2013 Estrogen Receptor AB-11 (Clone ID5) Mouse Monoclonal Antibody 1 mk (2mg.ml... Reports that the product is not performing as expected. In house testing showed no staining on br... Class II Lab Vision Corporation
Nov 26, 2013 outer box: Ref 906768, CurvTek Eye Needle 22 MM X-large Stainless Steel, Sin... Inner label of PN: 906768 Lot: 055450 CurvTek Eye Needle 22mm X-Large states incorrectly PN: 906... Class II Biomet, Inc.
Nov 26, 2013 BD Interlink threaded lock cannula This is a locking blunt plastic cannula s... BD Interlink Threaded Lock Cannula REF# 303369 and lot #3021392 is being recalled due to the pote... Class II Becton Dickinson & Company
Nov 19, 2013 Atrium Ocean Water Seal Chest Drain ATS Blood Recovery System with stopcock ... Chest Drain tubing of of the ATS Blood recovery may leak or disconnect Class II Atrium Medical Corporation
Oct 14, 2013 Philips brand IntelliSpace PACS 4.4, Image Management System; The system is a... Philips Healthcare became aware of a software problem with the IntelliSpace PACS system, in that ... Class II Philips Healthcare Informatics, Inc.
Oct 11, 2013 US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path ... St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary noti... Class II St. Jude Medical
Oct 10, 2013 The Verigene Gram-Positive Blood Culture Nucleic Acid Test (BC-UP) performed ... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Oct 3, 2013 Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical Blade Synthes Ti... A potential exists for non conforming Synthes Titanium Trochanteric Fixation Nail (TFN)-Helical B... Class II Synthes USA HQ, Inc.
Oct 1, 2013 Digital Pathology System (DPS) Software version 1.1 The Omnyx" Integrated ... There is an issue associated with Digital Pathology System (DPS) Software, in which the annotatio... Class II Omnyx Llc
Sep 30, 2013 Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... Class II Medtronic Neuromodulation
Sep 11, 2013 PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation. Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect sp... Class II SpineFrontier, Inc.
Sep 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... Class II Baxter Healthcare Corp.
Aug 26, 2013 Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating... Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... Class II Edwards Lifesciences, LLC

Frequently Asked Questions

When a device safety issue is identified, the manufacturer or FDA initiates a recall. The FDA publishes an enforcement report detailing the device, the reason for the recall, and distribution. Healthcare facilities and providers are notified to check their inventory and take corrective action.

All types, from simple devices like blood glucose test strips and surgical gloves to complex devices like pacemakers, defibrillators, insulin pumps, hip implants, and ventilators. Software-driven devices are increasingly common in recalls due to bugs and cybersecurity vulnerabilities.

Use the search and filter tools on this page. Each recall entry includes the device description, model numbers, and distribution details so you can determine if your device is affected. Contact your healthcare provider if you find a match.