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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
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way Red Latex Foley Catheter, 5cc (Council Model... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 3cc Foley Catheter, Rx only. Intended for u... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 BARDEX I.C. Anti-Infective 2-Way 5cc Foley Catheter. Intended for urinary bla... Labeling error: Catalog contains Instructions for Use (IFU) error; incorrect inflation volume. Class II C.R. Bard, Inc.
Dec 18, 2015 HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Co... This Lot is not meeting labeled on-board instrument stability claims of 5 days. Class II Instrumentation Laboratory Co.
Dec 17, 2015 Reprocessed Stryker Color Cuff and Color Cuff II Adult Tourniquet Cuffs Mo... Reprocessed Stryker Pressure Tourniquet Cuffs were mislabeled, including some labeled as single p... Class II Stryker Sustainability Solutions
Dec 9, 2015 Zimmer Universal Locking System 3.5mm Locking Reconstruction Plate Straight ... The product on the package label did not match what was inside the package. The label was for par... Class II Zimmer Biomet, Inc.
Dec 9, 2015 Zimmer Periarticular Locking Plate System 3.5mm Locking Screw 58 mm Length; ... Product on the package label did not match what was inside the package. The label was for part... Class II Zimmer Biomet, Inc.
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 Perkin Elmer ClWIZARD2 5-detector, 550 samples Product Code: 2470-0050, 3470... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 2-detector, 550 samples Product Code: 2470-0020 The Wiz... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 10-detector, 1000 samples. Product Code: 2470-0200, 347... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 5-detector, 1000 samples Product Code: 2470-0150, 3470-... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 Perkin Elmer WIZARD2 1-detector,3", 1000 samples. Product Code: 2480-0010 T... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 1-detector, 550 samples Product Code: 2470-0010 The Wiz... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 Perkin Elmer WIZARD2 10-detector, 550 samples Product Code: 2470-0100, 3470-0... The content of the second #023 barcode ID label in the Barcode ID Label Binder is incorrect. The... Class II Perkinelmer
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 8, 2015 SYNTHECEL Dura Repair, 510K # K131792, K113071, Class II, Classification name... It was reported that the SYNTHECEL Dura Repair could adhere to various anatomical structures post... Class II Synthes (USA) Products LLC
Dec 7, 2015 Excella II Rod Cat. No.: SR 55100 5.5 x 100 mm LOT 1502 and Excella II Rod ... Innovasis recalled two lots of Excella II titanium rods which were packaged using each other's la... Class II Innovasis, Inc
Dec 4, 2015 Synaptive Medical BrightMatter Navigator System (Guide System). Part number S... Out of tolerance for radio frequency emissions. At the 150-1000MHz frequency, the testing indicat... Class II Synaptive Medical, Inc.
Dec 3, 2015 Gynecare Thermachoice III Uterine Balloon Therapy System Ethicon, Inc. The... Stability data does not substantiate the labeled two-year shelf life of affected product. Class II Ethicon, Inc.
Dec 3, 2015 NexGEN System REF 5980-37-01 Tibial Component Size Stemmed 3 Precoat, and RE... A product complaint was received stating that a carton labeled as a Precoat Stemmed Tibia Size 3 ... Class II Zimmer Manufacturing B.V.
Dec 2, 2015 Label reading in part as: "NexGen System, Complete Knee Solution; Reference N... Complaints were received from Thailand reporting that there was no white paper (Tyvek) seal on th... Class II Zimmer Manufacturing B.V.
Dec 1, 2015 3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M... Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. Thi... Class II 3M Company - Health Care Business
Nov 30, 2015 Columbus Revision Knee System, EnduRo Knee System Product Usage: The Colu... Aesculap Inc. US has initiated a recall on Tibial and Femur extension sterile pressfit stem impla... Class II Aesculap, Inc.
Nov 25, 2015 Battery Power Line II Battery Oscillator, DePuy Synthes Power Tools, The Ansp... Has the incorrect operating directions on the mode switch ring, i.e. its is labeled "FWD, LOCK, R... Class II The Anspach Effort, Inc.
Nov 20, 2015 FMS neXtra¿ 3.5mm Full Radius Cutter Shaver Blades; Product Code: 283305 ... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 WARM STEAM Personal Steam Inhaler-Adjustable control to regulate flow of stea... "The public reason for the recall is that the product is being recalled out of an abundance of ca... Class II Bigwall Enterprises
Nov 20, 2015 FMS 3.5mm Ultra-Aggressive Cutter Shaver Blades; Product Code: 287325 Inte... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 20, 2015 FMS neXtra¿ 3.5mm Aggressive Cutter Shaver Blades; Product Code: 283315 In... Product is incorrectly labeled. The blade configuration in the affected lots does not match the d... Class II DePuy Mitek, Inc., a Johnson & Johnson Co.
Nov 19, 2015 VentriClear¿ II Ventricular Drainage Catheter Set. Allows external access an... Cook Medical initiated a voluntary recall of specific lot numbers of the VentriClear II Ventricul... Class II Cook Inc.
Nov 18, 2015 Dressit-X, Radiopaque D-545, NDC 11004-545-40, Dental Use Only, Active Ingred... Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... Class II Rainbow Specialty & Health Products
Nov 18, 2015 Dressol-X, Radiopaque D-502, NDC 11004-502-40, Dental Use Only, Active Ingred... Rainbow Specialty & Health Products initiated a field action for Dressol-X and Dressit-X because ... Class II Rainbow Specialty & Health Products
Nov 17, 2015 Merge RadSuite software. The firm name on the label is Merge Healthcare, Har... The values provided from the Pixel Value tool do not appear to be correct, which may result in po... Class II Merge Healthcare, Inc.
Nov 17, 2015 Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), ... PMMA is listed as a material on the label but the product does not contain PMMA. Class II Biomet, Inc.
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 7%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 16, 2015 BIRMINGHAM HIP RESURFACING MODULAR HEAD, REF numbers: 74121238, MODULAR HE... The 16 devices distributed in the United States were incorrectly labeled as the monoblock Birming... Class II Smith & Nephew, Inc.
Nov 16, 2015 Sodium Chloride Inhalation Solution, USP 3%, 60 x 4 mL Sterile Unit-Dose Vial... Lack of Assurance of Sterility: Internal dye ingress test failure to assure the integrity of the ... Class II Nephron Pharmaceuticals Corp.
Nov 12, 2015 Digital Temple Thermometer labeled under: Bestmed, Good Neighbor (Amerisource... An incorrect calibration of the thermometer that causes the device to display inaccurate and freq... Class II Bestmed, LLC
Nov 11, 2015 Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measuremen... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be use... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitativ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in ... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics Inc
Nov 11, 2015 Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be... Stratus CS Cartridge Barcode labels may not scan on the Stratus CS systems Class II Siemens Healthcare Diagnostics 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.