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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

5,543 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 5,543 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 5,543 FDA device recalls.

Clear
DateProductReasonClassFirm
Jul 21, 2017 FUJINON ED-530XT. This device is intended for the visualization of the duo... An update to the design and labeling was implemented to help reduce patient risk associated with ... Class II Fujifilm Medical Systems U.S.A., Inc.
Jul 21, 2017 SPIFE ImmunoFix-6 Kit, Cat. No. 3401, 3401T, For In-Vitro Diagnostic Use. Th... The plates do not have wells punched for the controls in the patient 1 area. Class II Helena Laboratories, Corp.
Jul 20, 2017 Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The fi... Reagent carryover from Sekisui ACTH when utilized on the BEC AU 680 analyzer may lead to falsely ... Class II Beckman Coulter Inc.
Jul 12, 2017 CORAIL COXA VARA HIGH OFFSET STEM Collared Size 9 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 12, 2017 CORAIL HIGH OFFSET STEM Collarless SIZE 14 Incorrect device in the package. A package that was labeled as the CORAIL COXA VARA HIGH OFFSET S... Class II DePuy Orthopaedics, Inc.
Jul 7, 2017 Mac Pin Non-Cannulated Screw, 6.5 x 60mm Incorrect labeling for the lot of MAC Pins. Although the pins are laser as 460 mm in length, t... Class II Amendia, Inc
Jul 5, 2017 LMA(TM) MADgic(TM) Laryngo-Tracheal Mucosal Atomization Devices: (a) MAD600 M... Teleflex Medical is recalling the affected product because there may be missing or incomplete inf... Class II Teleflex Medical
Jul 3, 2017 Beijing Syntech Laser Trixel C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Nice Station Light Based Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Trixel 11 C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO V+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser UL Station surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser Diode Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser UL C02 Laser surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jul 3, 2017 Beijing Syntech Laser APOLLO JV+ Medical Platform surgical lasers The noncompliance is that the certification label was not affixed on the product, with statement... Class II Beijing Syntech Laser Co., Ltd
Jun 30, 2017 731 Series Ventilators running software version 05.20.00 The devices in t... A software anomaly in the 731 software version 05/20/00, was identified, which can lead to a user... Class II ZOLL Medical Corporation
Jun 29, 2017 Medtronic Straight Suction 9733449 EM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Curved Suction 70 9733450 EM ENT, reusable, Rx. The firm name on t... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Kit 9733908 Fusion ENT, reusable, RX. This kit includes... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Set Supplemental INS AxiEM ENT, Ref. 9734378, reusable, RX. This k... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Curved Suction 90 9733451 EM ENT, reusable, Rx. The firm name on ... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Suction 9734308 Small AxiEM ENT, reusable, Rx. The firm name on th... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic Instrument Set EM ENT, Ref. #9733452 and #9733452-G02, reusable, R... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 29, 2017 Medtronic ENT Prgm 9734636 Add Fusion Nav AxiEM, reusable, Rx. This kit incl... The instruments are not able to pass instrument verification which is performed prior to the use ... Class II Medtronic Navigation, Inc.
Jun 27, 2017 Converters(R) Under Buttocks Drape with Fluid Control Pouch II, REF 8482, STE... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 27, 2017 Converters(R) Tiburon(R) Arthroscopy Drape, REF 9414, STERILE EO, Qty. 1, Car... Outer label of some units of product number/lot number 8482, Lot 16LFS235 and product number/lot ... Class II Cardinal Health 200, LLC
Jun 26, 2017 Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents incl... The kit box label incorrectly identifies PCP (instead of TCA) as one of the 10 drug analytes incl... Class III Ameditech Inc
Jun 21, 2017 PALLAS M/MAXIMIS Reduction A. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 250mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fix... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS S. Probe. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Rod Pusher Angled. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 5.5 x 50mm and 5.5 x 5.0 mm screw. Part of MAXIMI... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 60mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Reduction B. Part of MAXIMIS Pedicle Screw Spinal Fixation S... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 30 mm Curved Rod. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 50mm and 6.5 x 5.0 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 55mm and 6.5 x 5.5 mm screw. Part of MAXIMIS... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Poly Screw 6.5 x 40mm. Part of MAXIMIS Pedicle Screw Spinal ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Crosslink 50-70mm. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 7.5 x 45mm screw and 7.5 x 4.5 mm screw. Part of MAXIMIS Ped... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS I Handle. Part of MAXIMIS Pedicle Screw Spinal Fixation Syst... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Rod Bender. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Nut Driver 4.5 Star and Final Driver 4.0. Part of MAXIMIS Pe... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 7.5 x 55mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 35mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 45mm Straight Rod. Part of MAXIMIS Pedicle Screw Spinal Fixa... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS Compressor. Part of MAXIMIS Pedicle Screw Spinal Fixation Sy... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS 70mm MIS Rod. Part of MAXIMIS Pedicle Screw Spinal Fixation ... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Tapper 6.5mm. Part of MAXIMIS Pedicle Screw Spinal Fixat... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical LLC
Jun 21, 2017 PALLAS M/MAXIMIS MIS Screw 6.5 x 45mm. Part of MAXIMIS Pedicle Screw Spinal F... Devices are not consistent with Quality System Requirements. Class II Valorem Surgical 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.