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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

39,969 FDA medical device safety recalls.

FDA Medical Device Recall Enforcement Database

Browse 39,969 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 39,969 FDA device recalls.

DateProductReasonClassFirm
Jun 9, 2023 REF: 126590, MEDLINE, STERILE ULTRASOUND GEL, 0.70 FL oz. (20 mL), QTY: 50, S... Sterility of Ultrasound gel can not be guaranteed. Class II Turkuaz Saglik Hizmetleri Medikal Temizlik Kim....
Jun 8, 2023 Olympus EVIS EXERA II BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-P180, BF-Q1... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus BRONCHOVIDEOSCOPE BF Type, Model Numbers BF-P150, BF-1T150 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Argon Medical Devices, REF 352506070E, Option Elite Retrievable Vena Cava Fil... There is the potential that the vena Cava Filter may not perform as intended which may result in ... Class II Argon Medical Devices, Inc
Jun 8, 2023 Olympus OES BRONCHOFIBERSCOPE BF Type, Model Numbers BF-XT40, BF-P60, BF-MP60... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 BD Synapsys Informatics Solution, Catalog Number 444150 There is a risk of mis-association of patient demographic data for users who choose to report res... Class II Becton Dickinson & Co.
Jun 8, 2023 Olympus EVIS EXERA BRONCHOVIDEOSCOPE BF TYPE, Model Number BF-XT160 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus BRONCHOVIDEOSCOPE, Model Numbers BF-Q170 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 HF Resection Electrodes - HF resection electrodes are part of a resectoscope ... Additional Caution statements in IFU: (1) Due to complaints where the loop wire at the distal end... Class II Olympus Corporation of the Americas
Jun 8, 2023 Olympus EVIS EXERA III BRONCHOVIDEOSCOPE BF TYPE, Model Numbers BF-H190, BF-Q... There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 8, 2023 Olympus BRONCHOFIBERSCOPE BF Type, Model Numbers BF-PE2, BF-TE2 There have been complaints of endobronchial combustion during therapeutic laser procedures with t... Class I Olympus Corporation of the Americas
Jun 7, 2023 BeamAdjust software Version 2.3.3 Ref: S080032 The following devices are a... Generated calibration file will not be correct in case of a relative calibration of an OCTAVIUS D... Class II PTW-FREIBURG
Jun 7, 2023 FRED Flow Re-Direction Endoluminal Device, REF: FRED3507-PMA, FRED3511, FRED3... Intracranial aneurysm flow diverter device may be manufactured with an incorrect inner stent leng... Class II MICROVENTION INC.
Jun 6, 2023 GE Healthcare Giraffe Omnibed Carestation CS1, combination infant incubator a... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterier Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 NanoZoomer S360MD Slide scanner system-automated system for creating, viewing... If the wrong barcode information is recorded in the NDPi file, a pathologist may refer to the who... Class II Hamamatsu Corporation
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Vios Monitoring System Bedside Monitor, Model BSM2050, Software Version Numbe... A premature failure condition was identified with the L2050R pulse oximeter SpO2 sensor that conn... Class II Murata Vios, Inc.
Jun 6, 2023 Vanta with AdaptiveStim Implantable Neurostimulator, Model 977006; spinal cho... A cardioversion procedure may damage the electronics in the Vanta INS device, making the INS unre... Class II Medtronic Neuromodulation
Jun 6, 2023 OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy tha... 1. Wheels loosening over time with use of the device could lead to the inability to effectively d... Class II NeuroLogica Corporation
Jun 6, 2023 GE Healthcare Giraffe Incubator Carestation CS1, Infant Incubator. Model Numb... Prior to current established manufacturing practices, higher levels of airborne formaldehyde expo... Class I DATEX--OHMEDA, INC.
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System, Anterior Standalone Cage, ... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 6, 2023 Medtronic Catalyft LS Expandable Interbody System Implant Kit, Anterior Stand... There is the potential for out of specification device geometries. widths, lengths, heights, and... Class II Medtronic Sofamor Danek USA Inc
Jun 5, 2023 Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05. The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... Class II Exactech, Inc.
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Calibrators Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 Perifix¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 5, 2023 Verigene Enteric Pathogens Nucleic Acid Test (EP), REF 30-002-023 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022 It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022... Class II Luminex Corporation
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... An unexpected shutdown of the IABP may occur due to failures of tantalum capacitors in the Power... Class I Datascope Corp.
Jun 5, 2023 Cios Select VA 21 with FD- A Mobile X-ray system intended for use in Operatin... Incorrect glue was applied on the plexiglass sheet on the single tank cover assembly could potent... Class II Siemens Medical Solutions USA, Inc
Jun 5, 2023 Exactech Ergo Impactor Handle, Catalog #321-09-05. The ball and spring housed within the locking mechanism of the handle can dislodge during disasse... Class II Exactech, Inc.
Jun 5, 2023 Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 VITROS Immunodiagnostic Products Troponin I ES Reagent Pack Reagent packs could potentially contain incorrect wells, which will generate incorrect, and poten... Class II ORTHO-CLINICAL DIAGNOSTICS
Jun 5, 2023 Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0... IABP may lose the ability to charge batteries in one or both bay slots. Therapy may be interru... Class I Datascope Corp.
Jun 5, 2023 Design Options¿ / Epidural anesthesia kit (10 count carton) Kits were assembled with the incorrect Filter Straw. Class II B. Braun Medical, Inc.
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000, REF: B87352, IVD, 200240V, 1... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Beckman Coulter DxA Automation System, DxA 5000 Fit, REF: B87352, IVD, 200240... A software defect in the DxA Automation System may cause tests to be run on patient samples in tu... Class II Beckman Coulter Biomedical GmbH
Jun 2, 2023 Covidien Cytosponge Cell Collection Device, REF: CYTO-201; and Covidien Cytos... Cell Collection Device may be at increased risk of the sponge detaching from the string during re... Class II Covidien, LLC
Jun 1, 2023 epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Senso... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during elect... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc N... There is potential for discrepant high glucose results in samples with glucose results on the low... Class II Siemens Healthcare Diagnostics Inc
Jun 1, 2023 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosur... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, Inc.
Jun 1, 2023 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosu... Firm has received reports of patient burns in surgical procedures where device was used. Class I Megadyne Medical Products, 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.