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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

4,686 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 4,686 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 4,686 FDA device recalls in CA.

Clear
DateProductReasonClassFirm
Mar 4, 2014 Heart Mate II Pocket Controllers removed from packaging Product Usage: ... Discovery of serious injuries and deaths associated with the process of changing from a primary S... Class I Thoratec Corporation
Mar 4, 2014 Morphine Strip (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 Buprenorphine 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 Dengue IgG/IgM; 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 H. Pylori Ab 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 Malaria pf/pan 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 Malaria pf 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 Propoxyphene 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 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 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 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 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 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 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 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 20, 2014 PENTARAY NAV High-Density Mapping Catheter and PENTARAY NAV ECO Catheter, Cat... Biosense Webster is recalling the PentaRay Nav Catheter because it has the potential to have part... Class II Biosense Webster, Inc.
Feb 19, 2014 FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Dis... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 19, 2014 FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. S... Abbott Diabetes Care has identified through internal testing and investigation that all non-appli... Class I Abbott Diabetes Care, Inc.
Feb 18, 2014 Single Analyte DAU Calibrator (5 mL) Norbuprenorphine: Cutoff Calibrator; I... Customer reported that the Synchron NBUP cutoff calibrator (10 ng/mL) could not be qualified thro... Class III Lin-Zhi International Inc
Feb 14, 2014 Device Name: ABX PENTRA ML Model/Part #(s): A11A01652 Lot/Serial #(s): N/A ... HORIBA Medical initiated this recall of all software versions of ABX PENTRA ML (Model A11A06152) ... Class II Horiba Instruments, Inc dba Horiba Medical
Feb 13, 2014 VerifyNow IIb/IIIa Test, Catalog No. 85310, 10-Test Kit and Catalog No. 85011... Accumetrics is recalling the VerifyNow IIb/IIIa test because it may result in the reporting of an... Class II Accumetrics Inc
Feb 12, 2014 CartoUnivu Module, Model: Carto 3 Software versions 3.2.2 and 3.2.3; Catalog ... Biosense Webster has initiated a recall of the CartoUnivu Module within the Carto 3 System (V3.2... Class II Biosense Webster, Inc.
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.
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (37.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Contr... Class II Lin-Zhi International Inc
Feb 6, 2014 Cannabinoids DAU Calibrator Control Level 1 (62.5 ng/mL) This solution is ... Product catalog #s 0007c Cannabinoid 37.5 ng/mL Control Level 1 and 0008c Cannabinoid 62.5 Cont... Class II Lin-Zhi International 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.