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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

3,191 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,191 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 3,191 FDA device recalls.

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DateProductReasonClassFirm
Nov 7, 2022 Full Dose CE Simplex P Single Bone Cement - Indicated for the fixation of pro... Instructions for Use (IFU) included in the packaging is missing a translation in the Turkish lan... Class III Howmedica Osteonics Corp.
Nov 1, 2022 NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine dur... During accelerated shelf-life extension studies it was noted that the final packaging was experie... Class II NuVasive Specialized Orthopedics, Inc.
Nov 1, 2022 Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product D... Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalle... Class II Windstone Medical Packaging, Inc.
Oct 31, 2022 Unity Total Knee System. Used for knee prosthesis in total knee replacement The internal packaging system for devices may have damage to the blisters potentially damaging th... Class II Corin Ltd
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 2+ LEFT, REF ETPKN2PL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Oct 28, 2022 EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Ba... Class II MicroPort Orthopedics Inc.
Aug 30, 2022 Hammertoe Continuous Compression Implant (CCI) Kit Part Number: 46.239.001 Drill Pin (drill bit) is not compatible with the Drill Template included in the kit due to a pack... Class II Synthes (USA) Products LLC
Aug 16, 2022 Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire; Reference Part Number/... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (Nimble), Guidewire Reference Part Number/GPN: RFS... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Straight), Guidewire Reference Part Number/GPN: C-SF... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (Nimble Floppy), Guidewire RFPC-35-145 G07914 Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire Reference Par... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Coons Interventional Wire Guide, Guidewire; Reference Part Number/GPN: THSF... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide, Guidewire (OUS ONLY); Reference Part Number: TSMB-35-14... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY) Reference Part Number... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Lunderquist -Ring Torque Wire Guide, Guidewire Reference Part Number/GPN TH... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire; R... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm), Guidewire Reference Part Number/GPN RP... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Hydrophilic Wire Guide, Hydrophilic Guidewire Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Torq-Flex Wire Guide Australian Modification, Guidewire Reference Part Numbe... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Referen... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY); Reference Part N... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Rosen Curved Wire Guide, Guidewire Reference Part Number/GPN THSCF-35-220-1... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Roadrunner PC Wire Guide (The Firm LT), Guidewire Reference Part Number/GPN ... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire Reference Pa... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Vinyl Connecting Tube, Connecting Tube Reference Part Number/GPN CTU14.0-30... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Heavy Double Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 16, 2022 Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN... Cook Medical identified that devices from the affected device lots may have a complete breach of ... Class II Cook Incorporated
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 12, 2022 Humidifier bottle and syringe filter kit (6 count of each) for the BT37 Mark... There is a potential breach to the sterile barrier containing the Humidifier Bottles due to the p... Class II CooperSurgical, Inc.
Aug 10, 2022 Verify SixCess Challenge Pack. Used to confirm that critical parameters of s... Product contains incorrect chemical indicators in packaging. Class III Steris Corporation Hopkins Facility
Aug 3, 2022 Collagen Dental Wound Dressing - Bovine Dermis Tap, 25mm x 75mm Product wa... The packaging may not be sealed, which could compromise sterility. Class II Collagen Matrix Inc
Jul 27, 2022 Stryker SWANSON Flexspan Finger Joint Implant W/O Grommets Silicone, Size: 00... An incorrect sizing label was applied to the carton packaging. Class II Wright Medical Technology, Inc.
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Pink, 100 pack, RE... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Yellow: a) 25 pack... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, White REF H938671100 There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Purple, 100 pack, ... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Orange: a) 25 pack... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Green: a) 25 pack,... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 22, 2022 Baxter DISCPAC Syringe Tip Caps, Self-Righting, Luer Slip, Dark Blue: a) 25 p... There is a potential of the packaging not maintaining a sterile barrier for the tip caps. Class II Baxter Healthcare Corporation
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): RFSPC-35... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner UniGlide Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN): HP... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated
Jul 19, 2022 Roadrunner PC Hydrophilic Wire Guide REFERENCE PART NUMBER (RPN)RFPC-35-18... Product did not meet the acceptance criteria for packaging testing, which included 3-year age acc... Class II Cook Incorporated

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.