Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

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

Infrastructure

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

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

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.

Clear
DateProductReasonClassFirm
Aug 26, 2013 Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, ... Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involvi... Class II Edwards Lifesciences, LLC
Aug 19, 2013 Vision One Laser System Model GA-0025020, Serial No: 10050, 10051, 10053. ... Lumenis has initiated a recall on certain models of Vision One System due to a potential for unin... Class II Lumenis, Inc.
Jul 31, 2013 Synthes Matrix Threaded Persuader Deformity is a comprehensive thoracolumb... Synthes became aware that during a procedure using the Matrix Threaded Persuader, the Reduction I... Class II Synthes USA HQ, Inc.
Jul 31, 2013 Leica BIOSYSTEMS; BOND Polymer Refine Red Detection; Catalog No: DS9390; Leic... The affected lots of the product may contain a contaminant of fungus that can cause a loss of sta... Class II Leica Biosystems Newcastle Ltd.
Jun 12, 2013 Medtronic, Launcher Guiding Catheter, Model # LA8EBU45SH, Lot # 0006722866, ... Medtronic has identified a labeling issue for 24 units of the Launcher coronary Guide Catheter. ... Class II Medtronic Inc. Cardiac Rhythm Disease Management
Jun 5, 2013 Fisherbrand Sterile Swab, Calcium Alginate Fiber Tipped, Wood Applicator Swab... The firm is recalling Fisherbrand Sterile Swabs due to 4 customer complaints reporting the presen... Class II Fisher Scientific Co
May 24, 2013 AMICUS Exchange Kit; Product Usage: This kit is designed for use with th... Fenwal has initiated a voluntary Urgent Product Recall for lot FA12C07070 of product code R4R2339... Class II Fenwal Inc
May 10, 2013 Responder 5 is a nurse call communication system that connects patients with ... A counterfeited electronic component was identified in the products affected. The component, a da... Class II Rauland-Borg Corp
May 8, 2013 8 mm Monopolar Curved Scissors (a.k.a. Hot Shears) Manufactured and Distri... Intuitive Surgical has identified a potential for some units of the Monopolar curved Scissors ver... Class II Intuitive Surgical, Inc.
May 3, 2013 -ENDOPATH ETS-Flex Articulating Endoscopic Linear Cutter, (Blue) w/o Staples ... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 3, 2013 - ENDOPATH Resposable Bladeless Trocar, Non-Handled, w/Housing, 100mm, (Green... The seal which maintains a sterile barrier for reprocessed medical devices became compromised to ... Class II Surgical Instrument Service And Savings, Inc.
May 1, 2013 DMLC IV-ERGO Product Usage: Intended for use with rotating gantry linear ... It is possible for an intermittent error to occur in the gantry sensor of the DMLC IV Systems Class II Elekta, Inc.
Apr 19, 2013 Centricity Enterprise Archive is a software product for receiving, archiving ... GE Healthcare has become aware of a potential data loss issue associated with empty path names re... Class II Ge Healthcare It
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 11CC PLUS KIT, Product Code: 2839-10-000 ... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT, Product Code: 2839-05-000 The CON... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 17, 2013 CONFIDENCE SPINAL CEMENT SYSTEM KIT, Product Code: 2839-13-000 The CONFI... During injection of cement, the water in the hydraulic pump leaks past the piston within the pump... Class II DePuy Spine, Inc.
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L, bulk n... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier Convenience Kit (Flex Tra... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 12, 2013 LIGACLIP¿ Endoscopic Rotating Multiple Clip Applier (ER320), 10mm M/L Pro... Ethicon Endo-Surgery is initiating a voluntary recall for LIGACLIP¿ 10mm M/L Endoscopic Rotating ... Class II Ethicon Endo-Surgery Inc
Apr 9, 2013 HemosIL RecombiPlasTin 2G, Part Number 0020002950 (8 ml size). The product is... Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8... Class II Instrumentation Laboratory Co.
Apr 8, 2013 Endopath Electrosurgery Probe Plus II, twelve (12) different devices, includi... The firm is recalling the ENDOPATH Probe Plus II Shafts because the possibility that a tear in th... Class II Ethicon Endo-Surgery Inc
Mar 14, 2013 Edwards Lifesciences Duraflo coated Femoral Cannula. Product Usage: T... Two unsealed pouches were found at an Edwards' distribution location in Japan. Incorrectly seale... Class II Edwards Lifesciences, LLC
Mar 12, 2013 The Centricity Laboratory System is intended to be an information system desi... GE Healthcare has become aware of a potential safety issue associated with the use of GE Centrici... Class II GE Healthcare It
Mar 12, 2013 The Centricity Laboratory System is intended to be an information system desi... GE Healthcare is aware of a potential safety issue with the use of GE Centricity Laboratory Instr... Class II GE Healthcare It
Feb 6, 2013 Heritage Labs Path Study Extra Supplies Kit, Product # A 2376, kit contains 3... The product has a Lithium Heparin contaminant which could adversely affect coagulation results po... Class II Heritage Labs International LLC
Feb 4, 2013 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O... Class II Hospira Inc.
Feb 4, 2013 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and... Class II Hospira Inc.
Feb 4, 2013 Symbiq Two Channel Infuser; an Rx medical device infusion pump used to admini... Symbiq Infusers have the potential to experience a white screen during titration of a Keep Vein O... Class II Hospira Inc.
Feb 4, 2013 Symbiq One Channel Infuser; an Rx medical device infusion pump used to admini... Frequent Proximal Occlusion Alarms (POAs) occurring on Symbiq devices with list numbers 16026 and... Class II Hospira Inc.
Jan 23, 2013 MICROSHEATH¿ - 0.066 (1.7mm) proximal, 0.064 (1.6mm); WL 123cm, RGC 8F Guide;... Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard¿ UltraClip... Class II Bard Peripheral Vascular Inc
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 5CC KIT Catalog Number:283905000. D... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 7CC KIT Catalog Number: 283907000. ... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM KIT Catalog Number: 283913000. Del... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 15, 2013 DePuy CONFIDENCE SPINAL CEMENT SYSTEM 11C Plus KIT Catalog Number: 283910000... Cement mixer used to prepare cement for surgery may not turn properly and may jam or stuck Class II DePuy Spine, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH ST Product Code: GST60900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MP Product Code: GMD61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH ST Product Code: GST61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH S2 Product Code: GSM61000000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH HH Product Code: GMC51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MC Product Code: GCB61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH MPD Product Code: GMD60900000 Intended for ... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH ST Product Code: GST50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx90 GUIDING CATH MPC Product Code: GMC60900000 Intended for u... Sterility of device may be compromised due to lack of packaging integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH S2 Product Code: GSM51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH HH Product Code: GHH50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 6Fx100 GUIDING CATH HH Product Code: GHH61000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH S2 Product Code: GSM50900000 Intended for us... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx100 GUIDING CATH ST Product Code: GST51000000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MPC Product Code: GMC50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.
Jan 11, 2013 NEUROPATH 5Fx90 GUIDING CATH MCV Product Code: GCB50900000 Intended for u... Sterility of device may be compromised due to lack of package integrity Class II Codman & Shurtleff, Inc.

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.