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

3,010 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,010 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 3,010 FDA device recalls in 2019.

Clear
DateProductReasonClassFirm
Mar 14, 2019 Dense Bone Drill WP 5x13 mm Single-Pat - Product Usage: Drills are intended t... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered RP 4.3x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Drill Tapered NP 3.5x11.5 mm Single-Pat - Product Usage: The Guided Drills (T... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 14, 2019 Guided Start Drills/Counterbore NobRpl NP - Product Usage: The Guided Drills ... Due to a problem in the packaging sealing process at the supplier of the affected devices, it can... Class II Nobel Biocare Usa Llc
Mar 13, 2019 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... Class II Medical Components, Inc dba MedComp
Mar 13, 2019 Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 ... 2.5 Truliant Fit Trays were mismarked as 3 Class II Exactech, Inc.
Mar 13, 2019 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... Class II Medical Components, Inc dba MedComp
Mar 13, 2019 enFlow Disposable Cartridge with IV Extension Set, used for intravenous warmi... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warm... Class I Vyaire Medical
Mar 13, 2019 enFlow Disposable Cartridge, used for intravenous warming therapy with fluid ... Testing has demonstrated aluminum elution from the enFlow Disposable Cartridge during fluid warming. Class I Vyaire Medical
Mar 13, 2019 Procedure kits include devices from the affected lots distributed OUS only: ... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, I... Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... Class II Medical Components, Inc dba MedComp
Mar 13, 2019 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No.... Tray label indicates the kits are packaged with a 15F "valved" peelable introducer, but the kits ... Class II Medical Components, Inc dba MedComp
Mar 13, 2019 Covidien Endo Grasp Auto Suture Grasper 5mm REF: 173030 The Covidien Endo... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 13, 2019 Covidien Endo Clinch II Auto Suture Grasper, 5mm REF: 174317 The Covidi... Sterilization method used was not consistent with the labeling and the approved sterilization method Class II COVIDIEN LLC
Mar 12, 2019 VICRYL Sutures VICRYL SUTURE 18"(45CM) 0 VIO VICRYL SUTURE 18"(45CM) 4-0 UN... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 12, 2019 Beaver Xstar Slit Knife 2.4 mm, 45degree Double Bevel, Ophthalmic-utilized i... Mislabeled. The package labeling indicates a size 2.4mm, 45 degree Double Bevel knife however, th... Class II Beaver Visitec
Mar 12, 2019 VICRYL PLUS Sutures: VICRYL PLUS SUTURE 18"(45CM) 3-0 VIO VICRYL PLUS SUTU... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 12, 2019 Azurion FlexArm, 722079 During manufacturing of an Azurion R2.0 system, it was found out that the cable set was not accor... Class II Philips North America, LLC
Mar 12, 2019 PDS II SUTURE 18"(45CM) 2-0 VIO Product Code:Z739D - PDS Sutures are intende... VICRYL Suture, VICRYL Plus Suture, PDS Suture- may contain product that does not match the sales ... Class II Ethicon, Inc.
Mar 12, 2019 Elekta Unity, Image-Guided Radiation Therapy System Product Usage: Elekta... Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The... Class II Elekta Limited
Mar 11, 2019 RT Elements Software revisions of the RT Elements applications have a speci... There is a potential for an incorrect dose distribution calculation by Brainlab RT Elements softw... Class II Brainlab AG
Mar 11, 2019 ACUVUE OASYS for ASTIGMATISM brand contact lenses, Base Curve 8.6 Refractive ... One lot of ACUVUE OASYS¿ for ASTIGMATISM Brand Contact lenses has the potential for a limited num... Class II Johnson & Johnson Vision Care, Inc.
Mar 11, 2019 Liquid Cardiac Control, Model Nos. CQ5051, CQ5052, CQ5053 Customers may observe a decrease in recovered concentration with regards to NTproBNP in the Liqui... Class II Randox Laboratories Ltd.
Mar 11, 2019 VITROS XT 7600 Integrated System, Product Code 6844461, UDI 1075870031658 ... One of the software algorithms used to detect sample dispense errors was inadvertently disabled. ... Class II Ortho-Clinical Diagnostics
Mar 8, 2019 Salto Talaris, Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 0, Right,... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 1, Right, Product No. LJU811T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Olympus Diego Elite Console MDCONS 100 Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 3, Product No. LJU223T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part No: BB4000SC Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 0, Product No. LJU220T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Diego Elite Malleable, 4mm Standard Monopolar Blades Product Code:MM4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 2, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 3, Right, ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number: BB... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Tibial Total Ankle Prosthesis Tray, Size 1, Product No. LJU221T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm curved, Product Number:BB4... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 0, Right, Product No. LJV180T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Left, Product No. LJV193T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 1, Right, Product No. LJV181T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Diego Elite Turbinate Blades Bipolar Blade, 4mm straight, Part Number: BB40... Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Right, Product No. LJU812T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Ankle Prosthesis Tray, Talar Dome, Size 1, Right, Part ... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 2, Left, Product No. LJU822T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Flat Cut, Size 3, Left, Product No. LJU823T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis , Sloped, Size 3, Right, Product No. LJV183T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Sloped, Size 2, Right, Product No. LJV182T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the ... Certain Torque Limiting Handles in the field are beyond their 3 year calibration life. Class II ulrich medical USA Inc
Mar 8, 2019 Diego Elite Blades Monopolar, 4mm Straight, TIA Product Code:MB4000SS Olympus Diego Elite Consoles may inadvertently permit activation of the RF energy feature when us... Class II Gyrus ACMI, Inc.
Mar 8, 2019 Talar Dome Total Ankle Prosthesis, Flat Cut, Size 1, Left, Product No. LJU821T The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.
Mar 8, 2019 Salto Talaris Tibial Total Ankle Prosthesis Tray, Talar Dome, Size 1, Left, P... The Salto Talaris and Integra XT Revision implant labelling was found to list an incorrect metall... Class II Integra LifeSciences Corp.

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.