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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

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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.

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DateProductReasonClassFirm
Jul 3, 2012 Fona Srl IntraOs 70 intra-oral x-ray system IntraOS 70 is an extra oral so... The IntraOs 70 system was found to have missing or incomplete system labels as required by 21 CFR... Class II Chicago X-Ray Systems, Inc.
Jun 29, 2012 MXR-35 Diagnostic X-ray High Voltage Generator manufactured by DRGEM Corporat... The MXR-35 X-ray Generator's labeling did not include the certification statement as required by ... Class II Fujifilm Medical System USA, Inc.
Jun 28, 2012 STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, pac... Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biolo... Class II Advanced Sterilization Products
Jun 26, 2012 GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal... Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak In... Class I GE Healthcare, LLC
Jun 20, 2012 System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 ... During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3) Sa... Class III Terumo Cardiovascular Systems Corporation
Jun 18, 2012 MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for ... Synthes is initiating a Medical Device Labeling Correction following a detailed review of the cur... Class II Synthes USA HQ, Inc.
Jun 15, 2012 AngioDynamics Angiographic catheter --- Soft-Vu (JB-1) Non-braided. --- Size:... AngioDynamics is recalling one lot of Soft-Vu Angiographic catheters because one of the catheter ... Class II Angiodynamics Worldwide Headquarters
Jun 15, 2012 Equinoxe Reverse Shoulder Fracture Adapter Tray Screw Intended for Primary... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total ... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Reverse Glenosphere Locking Screw Intended for Primary and Revers... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Tot... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 15, 2012 Octane-C Cervical, 6¿ Lordotic Intended for anterior cervical spine interver... Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinox... Class II Exactech, Inc.
Jun 14, 2012 OrthoPediatrics PediLoc Locking Plate System, 4.5mm Contour Locking Compressi... The device is a Left 8 hole plate but is incorrectly labeled and etched as a Right device. Class II OrthoPediatrics Corp
Jun 8, 2012 NeuViz 16 Multi-Slice CT Scanner System is a computed Tomography X-ray system... One of the four screws that secure the Oil-accumulator to the X-Ray Tube pulled out in the NeuViz... Class II Philips And Neusoft Medical Systems Co., Ltd.
Jun 8, 2012 Neptune 1 Gold Rover (120 Vand 230V ) Waste Management System Part Number 070... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Stryker Neptune Bronze Rover, Part 0700-007-000 Neptune Bronze Rover Waste M... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Neptune Rover Waste Management System, Neptune 2 Ultra Intended for use in t... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 8, 2012 Neptune 1 Silver Rover, Part 0700-003-000 Stryker Instruments Neptune Rover ... Stryker has received two reports of serious injury as a result of tissue damage associated with t... Class I Stryker Instruments Div. of Stryker Corporation
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 10 mm Exposure, Single Use ... The Tyvek pouch label for this device states: 'with holster'; however, this product does not com... Class II PSC Industries Inc
Jun 5, 2012 Button Switchpens, w/Extendable Needle Electrode 2 mm Exposure Single Use Ele... The carton label for this device has the manufacturer symbol where the expiration date symbol sho... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 8.25 (209.6 mm) 0.5mm Tips, Sterile Single Use Surgical/Bipol... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Insulated Tips, Sterile Single Use S... Firm officials reported to CIN-DO that the outer carton label of this sterile, single use device ... Class II PSC Industries Inc
Jun 1, 2012 Bayonet Forceps 8.5" (215.9mm) Serrated 1.0 mm Tips Electrosurgical/Monopolar... Firm officials reported to CIN-DO that their Electrosurgical Monopolar Reusable Bayonet Forceps ... Class II PSC Industries Inc
Jun 1, 2012 Irrigating Bayonet Forceps 8.25" (209.6 mm) 1.5 mm Tips, Electrosurgical Irri... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
Jun 1, 2012 CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho... The recall was initiated because Advanced Sterilization Products has discovered instances of miss... Class II Advanced Sterilization Products
Jun 1, 2012 Bayonet Forceps 7.-1/8 (181.0mm) 0.75mm Non-Insulated Tips, Sterile Single Us... Firm officials reported to CIN-DO that for this device, in the labeling on the inner Tyvek peel ... Class II PSC Industries Inc
May 31, 2012 Low Profile Abutment, Non-Hexed Castable Cylinder Model LPCCC1. Product is l... Biomet 3i conducted a recall on the device Low Profile Abutment, Non-Hexed Castable Cylinder due ... Class II Biomet 3i, LLC
May 30, 2012 Adult Divided Cannula end tidal C)2 sampling w/male luer-lock connector. 7 f... A complaint was received, and later verified, that product labeled as SO-1296 with male luer lock... Class II SALTER LABS
May 29, 2012 IDEV Technologies SUPERA VERITAS Interwoven Self-Expanding Nitinol Stent Tran... There was an error on the outer labeling of this device. The inner label was correct. Class II IDEV Technologies, Inc.
May 29, 2012 Advantage Workstation Volume Share 2 (versionAW4.4_04) with Volume Viewer 3 a... GE Healthcare has became aware of two issues with the Advantage Workstation. 1) A possible mis... Class II GE Healthcare, LLC
May 25, 2012 Alaris PC unit model 8015 Product Usage: The device is labeled for prescr... The recall was initiated because the Alaris PC unit model 8015 has a component on the PC unit pow... Class I CareFusion 303, Inc.
May 24, 2012 Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, ... Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10... Class II Ultradent Products, Inc.
May 24, 2012 AdvantageSim MD versions 7.4 through 7.6, Model 5160092-2 Version 7.4, 516009... It was reported by a customer site that when using GE AdvantageSim MD on Advantage Workstation, t... Class II GE Healthcare, LLC
May 24, 2012 EkoSonic MACH4 Endovascular Device (Catalog #500-55106, 500-55112; 500-55118;... EKOS Corporation have recently received several complaints from users where the radio-opaque mark... Class II EKOS Corporation
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog # 441401, 200 box tests 2-3 labeled in pa... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 CYTO-STAT tetraCHROME CD45- FITC/CD56-RD1/CD19-ECD/CD3-PC5, Part Number 66070... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 BD GeneOhm Cdiff Assay , Catalog #441400 200, box tests 1-3 labeled in part**... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm MRSA ACP Assay, Catalog #441639, box 200 tests labeled in part***G... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 BD GeneOhm VanR Assay , Catalog # 441250, 5 box tests labeled in part***Gene... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 22, 2012 4.5mm TI Multiloc Screw Length 28MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 TetraCXP Software System, Part Number A40051. Allows simultaneous identifi... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 4.5mm TI Multiloc Screw Length 38MM-Sterile Expiration: 04/29/2012 REF 04.0... Two lots of 4.5mm multi-loc screws were recalled due to incorrect labeling of screw size. Class II Synthes USA HQ, Inc.
May 22, 2012 CYTO-STAT tetraCHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5, Part Number 6607013.... The recall was initiated because Beckman Coulter has determined that the specimen and prepared sa... Class II Beckman Coulter Inc.
May 22, 2012 BD GeneOhm MRSA ACP Assay Catalog #441637, box 48 tests labeled in part***Gen... Leakage in Cepheid SmartCycler reaction tubes. Class II Becton Dickinson & Co.
May 21, 2012 Olympic Cool-Cap System is intended to provide treatment for neonatal hypoxi... Olympic Cool-Cap Cooling Module's power supply failed during treatment. The power supply failure... Class II Natus Medical Incorporated
May 12, 2012 Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instr... Bigliani/Flatow The Complete Shoulder Solution Trabecular Metal Glenoid Instrument Drill with Sto... Class II Zimmer, Inc.
May 11, 2012 The product is Pathfinder SL, version 1.6.0.3057 software used with the Space... The firm received reports of the Pathfinder LS software crashing after editing a batch of Holter ... Class II Spacelabs Healthcare, Llc
May 9, 2012 The product has the Catalogue/Part number 60010. Olympic Cool-Cap System i... The Olympic Cool-Cap's Control Module has experienced a frozen screen during use. When this occur... Class I Natus Medical Incorporated
May 7, 2012 US-001 Rev A brochure is a two sided tri-fold printed marketing brochure desc... Non-Invasive Monitoring Systems Inc (NIMS) is voluntarily recalling promotional materials which c... Class II Non-Invasive Monitoring Systems, 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.