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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

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

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Browse Device Recalls

2,729 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,729 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 2,729 FDA device recalls in 2014.

Clear
DateProductReasonClassFirm
Mar 4, 2014 Malaria pf Antigen Test Card; Flumiquil, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Morphine Test Card (300); LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 PSA Test Card (Serum); LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Legionella Test Card; LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 HeartMate II LVAD Pump and Pock Controller Kit; Product Usage: HeartMat... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 HeartMate II System Controller Product Usage: HeartMate II is a mechanica... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 THC Test Card; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Methadone Test Card; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Methylphenidate Test Card; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Amphetamine Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Salmonella typhi Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Tramadol Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Methamphetamine Test Card; LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Dengue NS1 Ag/IgG/M Ab Duo Test Card; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Methylphenidate Test Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Oxycodone Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Ketamine Strip; LumiQuick,. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Barbiturate Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 EDDP Test Card; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Morphine Strips (2000); LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Cocaine Test Card; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Fecal Occult Blood Test Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Benzodiazepine Strip; LumiQuick. Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 4, 2014 Adenovirus Antigen Test Card; LumiQuick, Santa Clara, CA 95054 Products shipped to US locations that do not have approved applications for PMA , IDE or 510(k) c... Class II LumiQuick Diagnostics Inc.
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
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 FIBERNET Embolic Protection System: Recommended Vessel Diameter 3.5 0 5.0 mm... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarn... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarn... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
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.
Mar 3, 2014 Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connect... During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed baske... Class II Terumo Cardiovascular Systems Corporation
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 5.0 -6.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Mar 3, 2014 Boston Scientific, RunWay Guide Catheter, UPN H749389696640, Catalog Number 3... The sterile pouch of the devices from this lot may not be completely sealed and sterility may be ... Class II Boston Scientific Corporation
Mar 3, 2014 FIBERNET Embolic Protection System: Recommended Vessel Diameter 6.0 -7.0 mm,... Medtronic is recalling a specific subset of lot numbers of the FIBERNET Embolic Protection System... Class II Medtronic Vascular, Inc.
Feb 28, 2014 Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America Inc.
Feb 28, 2014 GE Healthcare CARESCAPE Monitor B650 and CARESCAPE Monitor B850. K102239 C... GE Healthcare has recently become aware of potential safety issues associated with the CARESCAPE ... Class II GE Healthcare, LLC
Feb 28, 2014 Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound i... A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will r... Class II Philips Medical Systems North America Inc.
Feb 28, 2014 Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube se... The product may fail to achieve seal of right lung due to the cuff inflating to one side Class II Teleflex Medical
Feb 28, 2014 Omni Micro-electrode/reference electrode for cobas b221 analyzer, Model/Cata... Reference electrode used beyond the guaranteed in-use 52 week lifetime,may leak and potentially ... Class II Roche Diagnostics Operations, Inc.
Feb 27, 2014 Ovation Prime Abdominal Stent Graft System; Manufacturer: TriVascular, Inc.... Communication to European physician users of the Ovation Prime Abdominal Stent Graft system to no... Class II Trivascular, Inc
Feb 27, 2014 Medtronic, External neurostimulator, ENS (37021) & ENS (37022). Including t... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Di... Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator wit... Class II Megadyne Medical Products, Inc.
Feb 27, 2014 Medtronic neurostimulators. Restore (37711), RestoreADVANCED (37713), Restore... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 Medtronic Activa RC (37612), Activa PC (37601), Activa SC (37602), Activa SC... Medtronic neurostimulators (used with pain and deep brain stimulation therapy) have a cycling fea... Class II Medtronic Neuromodulation
Feb 27, 2014 PowerPort Slim Implantable Port, indicated for patient therapies requiring re... Labeling discrepancy.The label states that the implantable port contains silicone suture plugs, h... Class II Bard Access Systems
Feb 27, 2014 D-10" Hemoglobin Testing System, Model number: 220-0220 Manufactured by:... On a rare occasion the D-10 software might generate an extra result by duplicating the result for... Class II Bio-Rad Laboratories, Inc.
Feb 26, 2014 Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biom... Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was id... Class II Biomet, 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.