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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

2,522 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 2,522 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 2,522 FDA device recalls.

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DateProductReasonClassFirm
Oct 13, 2013 Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if ster... Reports of discoloration (residue) on the pins of the skin tensioner have been received by severa... Class II Restoration Robotics
Oct 10, 2013 Juggerknotless Drill Bit, REF 110003173, Sterile, Single Use Product Usa... Investigation identified that the design of the drill bit may make the suture anchor difficult to... Class II Biomet, Inc.
Oct 10, 2013 The Verigene Enteric Pathogens Nucleic Acid Test (EP) is a multiplexed, quali... Nanosphere has received several reports relating to an increased rate of Processing Errors during... Class II Nanosphere, Inc.
Sep 30, 2013 Merit Medical's Custom Procedural Trays or Kits containing 1% Lidocaine HCl I... Custom Procedural Trays/Kits contain 1% Lidocaine HCl injection which were recalled because one c... Class I Merit Medical Systems, Inc.
Sep 30, 2013 Medtronic RestoreUltra, model 37712, and RestoreSensor, model 37714, Multi-pr... Medtronic notified customers regarding over stimulation or stimulation in the wrong area related ... Class II Medtronic Neuromodulation
Sep 30, 2013 Synthes Zero-P VA Implant 7 MM Height Parallel Sterile The Synthes Zero-P ... A potential non conformance was identified with the Zero-P VA plate where the screw could back ou... Class II Synthes USA HQ, Inc.
Sep 24, 2013 COULTER LH 750 and LH 780 Analyzers. The COULTER LH 750 Hematology Analyz... The check valves may fail on the Coulter LH 750 Hematology Analyzer (PN 6605632 and A85570) and C... Class II Beckman Coulter Inc.
Sep 23, 2013 Portex¿ Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthe... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Ane... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Ane... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 Th... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesth... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-2... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthe... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional An... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Portex¿ Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesth... Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 m... Class II Smiths Medical ASD, Inc.
Sep 23, 2013 Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, st... The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sh... Class I Baylis Medical Corp *
Sep 10, 2013 Dual Luer Lock Cap The device is intended for use as a cap for male or fem... The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging... Class II Baxter Healthcare Corp.
Aug 30, 2013 Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. ... Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (L... Class II Implantech Associates Inc
Aug 29, 2013 Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillat... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Aug 29, 2013 Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E11... The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufact... Class II Boston Scientific CRM Corp
Aug 29, 2013 Composite Series Skull Clamp, one clamp per tote. The MAYFIELD¿ Skull Cla... An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not eas... Class II Integra LifeSciences Corp.
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), ... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), R... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), RE... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 27, 2013 GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1... The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert... Class II Smith & Nephew Inc
Aug 22, 2013 Surgicutt fully automated incision making device for bleeding time determinat... ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; L... Class II ITC-Nexus Dx
Aug 16, 2013 Ingenuity TF PET/CT Diagnostic imaging system for fixed or mobile installa... Issues with the Ingenuity TF PET/CT Software Version 4.0 could pose a risk for patients in the ev... Class II Philips Medical Systems (Cleveland) Inc
Aug 5, 2013 3M ESPE Unitek Primary Stainless Steel Crowns (First Primary UL4), Product co... 3M ESPE is recalling Unitek Primary Stainless Steel Crowns (First Primary UL4) because these prod... Class II 3M Company/3m Espe Dental Products
Jul 31, 2013 Boston Scientific, FlextomeTM Cutting BalloonTM, Sterilized using irradiatio... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 31, 2013 2.4 and 2.7 MM Locking Screw SLF-TPNG with T8 Stardrive Recess 12 MM Fixatio... Specific lots of the SS 2.4mm and SS 2.7mm Locking Screw (self-tapping) due to a mislabeling issu... Class II Synthes USA HQ, Inc.
Jul 31, 2013 Boston Scientific, Small Peripheral Cutting BalloonTM, Sterilized using irrad... Boston Scientific is initiating a recall removal of the 4.0mm x 15mm size of Small Peripheral Cut... Class II Boston Scientific Corporation
Jul 30, 2013 ZIMMER PERIARTICULAR LOCKING PLATE SYSTEM DISTAL MEDIAL HUMERAL LOCKING PLAT... Zimmer is initiating a lot specific voluntary recall of the Distal Medial Humeral Locking Plate, ... Class II Zimmer, Inc.
Jul 30, 2013 Synthes 2.4 VA-LCP 2 CLMN VLR DSTL Radius PL 7H HD/3H Shaft/Right Product ... The possibility exists that 2.4 mm VA-LCP 2 column distal radius plates from a specific lot are e... Class II Synthes USA HQ, Inc.
Jul 12, 2013 Flixene IFG Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts >or= 6mm Intended for use in arterial vascular reconstruc... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts <6mm Intended for use in arterial vascular reconstruction,... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts >or= 6mm Intended for use in arterial vascular reco... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene IFG with Assisted Delivery Intended for use in arterial vascular re... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SuperSoft Grafts <6mm Intended for use in arterial vascular reconstr... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Trumpet Grafts >or= 6mm Flixene GW and GWT Grafts >or= 6mm Intended... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta SST Bifurcated Grafts >or= 6mm Intended for use in arterial vascular... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Grafts <6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VXT Vascular Grafts >or= 6mm Intended for use in arterial vascular r... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Advanta VS Grafts >or= 6mm Intended for use in arterial vascular reconstruct... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation
Jul 12, 2013 Flixene Grafts >or= 6mm Intended for use in arterial vascular reconstruction... Inner tray label may adhere to wall of outer tray which make it difficult to remove the tray onto... Class II Atrium Medical Corporation

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.