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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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Browse Device Recalls

3,313 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 3,313 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 3,313 FDA device recalls in 2017.

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DateProductReasonClassFirm
Jan 9, 2017 Regard, Item Number: 800415002, Sterile, OR0484B- Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800558004, Sterile, OR0647D - Extremity - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800036005, Sterile, LD0274E - C Section Pack - FMOL St ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800422003, Sterile, OR0491C - Arthroscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880323001, Sterile, LD0754A - C Section - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800533001, Sterile, GS0606A - Abdominal Pk - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800410003, Sterile, CV0479C - Open Heart PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800524003, Sterile, LD0608C - C Section - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800419002, Sterile, GY0488B - D&C Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 GN200 Caiman HF generators, electrosurgical, cutting & coagulation & accessories Generators may have a faulty component which could impact the proper functioning of the device. Class II Aesculap Implant Systems LLC
Jan 9, 2017 Regard, Item Number: 800326002, Sterile, GS0757B - Major Basin - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800562002, Sterile, NU0651B - Neuro - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800414002, Sterile, OR0483B- Total Joint Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800508004, Sterile, LD0586D - C Section - Jasper Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800414003, Sterile, OR0483C - Total Joint Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800557001, Sterile, LD0646A - C Section - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800562001, Sterile, NU0651A - Neuro - Childrens Santa Rosa Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800417002, Sterile, GY0486B - Laparoscopy Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800091002, Sterile, LD0692B - C Section - FMOL Lady of ... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800528002 Sterile, GS0612B - Lap Chole PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 STERRAD NX Sterilization System, Product Code: 10033, 10033-002 Advanced Sterilization Products (ASP) has identified that in a rare sequence of events following ... Class II Advanced Sterilization Products
Jan 9, 2017 Regard, Item Number: 880328001, Sterile, HT0759A - Pacemaker Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800535001, Sterile, LD0620A - C Section - New Braunfels Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800415001, Sterile, OR0484A - Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800430005, Sterile, LD0499E - C Section Pk - Cabrini Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800413005, Sterile, CV0482E- Vascular PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800528005 Sterile, GS0612E - Lap Chole PK - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800560003, Sterile, GS0649C - Lap Chole - Childrens San... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880328002, Sterile, HT0759B - Pacemaker Pk - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800560002, Sterile, GS0649B - Lap Chole - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800558003, Sterile, OR0647C - Extremity - Childrens Sant... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800550001, Sterile, OR0639A - Hip Shoulder - Medical Cen... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 880326001, Sterile, GS0757A - Major Basin - OSU Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800567003, Sterile, GY0656C - Robotic Hysterectomy - Alamo Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800410004, Sterile, CV0479D- Open Heart PK - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800551002, Sterile, GS0640B - Lap Chole - Medical Center... Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800415003, Sterile, OR0484C- Shoulder System Pk - Spohn Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 9, 2017 Regard, Item Number: 800526003 Sterile, ET0610C - Head and Neck - Westover Hills Custom procedure trays contain a component, a light glove, that has been recalled by the manufact... Class II Resource Optimization & Innovation Llc
Jan 8, 2017 Laerdal Compact Suction Unit ¿ 4 under the following labels: 1) 300 ml (3.3 l... The On/Off functionality in the LCSU 4 is controlled by electronic components, one of which might... Class II Laerdal Medical Corporation
Jan 7, 2017 Olympus Scientific Solutions Americas Corporation (OSSA) VANTA¿ XRF Analyz... It was discovered under rare circumstances the LED warning light circuit could fail. If this happ... Class II Olympus Scientific Solutions Americas
Jan 6, 2017 C2 CryoBalloon Ablation System - Controller Cap. C2 CryoBalloon Controller; ... The Controller Cap of the C2 CyroBalloon Ablation System may crack as it is tightened onto the co... Class II C2 Therapeutics, Inc.
Jan 6, 2017 DePuy Synthes various orthopedic instruments modified by U.S. Distributors ... Products were made outside of Quality System Regulation, and potentially outside of premarket sub... Class II DePuy Orthopaedics, Inc.
Jan 6, 2017 Color contact lenses labeled under the following brands: Diamond, Fierce, Amb... Sterility and Misbranding: Lenses may not be sterile and may be labeled with erroneous lot number... Class II The See Clear Company
Jan 6, 2017 Hitachi Oasis MRI System - C-Spine Coil The customer indicated that the coil balun was hot to the touch when removing the coil from the p... Class II Hitachi Medical Systems America Inc
Jan 5, 2017 Genetic Screening Processor (GSP); PerkinElmer Part Number= 2021-0010 Inte... The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... Class II PerkinElmer Life and Analytical Sciences, Walla...
Jan 5, 2017 Spare Disk Remover Module; Product Number: 61001820 Intended for in vitro ... The firm became aware that the ball bushing axels are defective in the GSP instrument. During exp... Class II PerkinElmer Life and Analytical Sciences, Walla...
Jan 5, 2017 VITROS Chemistry Products FS Calibrator 1, REF 680 1873 12 x 3 mL, Rx ONLY, I... The company received a customer complaint for the inability to calibrate VITROS Chemistry Product... Class III Ortho-Clinical Diagnostics
Jan 5, 2017 EyeSuite i.8.2.1.0 Software for ophthalmic use including selection of Intra O... There is a possibility for data to be stored under the wrong patient on the DICOM Server followin... Class II Haag-Streit USA Inc
Jan 4, 2017 AFX Endovascular AAA System Item Number Item Description F0070305 ... Endologix updated information on the rates of Type III endoleaks and suggestions for patient surv... Class II Endologix
Jan 4, 2017 Maintenance Kit PH1, Cod. 6997266 The Phoenix Hemodialysis delivery system i... Baxter Healthcare Corporation is issuing a voluntary product recall for several lots of Phoenix D... Class II Baxter Healthcare 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.