{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216118", "product_res_number": "Z-0043-2026", "event_date_initiated": "2025-09-18", "event_date_posted": "2025-10-10", "recall_status": "Open, Classified", "res_event_number": "97615", "product_code": "MIH", "pma_numbers": [ "P140016" ], "product_description": "Zenith Alpha 2 Thoracic Endovascular Graft, Catalog Prefix ZTA2-\n\nReference Part 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"recalling_firm": "Cook Medical Incorporated", "address_1": "400 N Daniels Way", "city": "Bloomington", "state": "IN", "postal_code": "47404-9155", "additional_info_contact": "Cook Medical Customer Relations Department\n800-457-4500", "reason_for_recall": "Affected devices may contain PTFE coating scrapings. Scrapings could be released during device deployment, potentially causing intravascular embolization.", "root_cause_description": "Process design", "action": "On September 18, 2025, the recalling firm sent Urgent Medical Device Recall letters to all affected customers.\n\nCustomers were instructed to identify and quarantine unused affected product in inventory. Immediately cease all further distribution and use of the affected products. Affected product is to be returned to Cook Medical.", "product_quantity": "695", "distribution_pattern": "Domestic distribution to AL\nAR\nAZ\nCA\nCT\nDC\nDE\nFL\nGA\nIL\nIN\nLA\nMA\nMD\nMI\nMN\nMO\nNC\nNJ\nNY\nOH\nOR\nPA\nSC\nTN\nTX\nUT\nVA\nWA\nWI\nWV\n\n\nInternational distribution to Switzerland, Germany, Italy, Poland, and Sweden", "openfda": { "pma_number": [ "P040043", "P210032", "P070027", "P100040", "P040002", "P120006", "P140016", "P020004", "P190015", "P110038", "P990020", "P100021", "P150002", "P180001", "P990017", "P200030", "P020018", "P070016", "P200045", "P110032", "P070007" ], "device_name": "System, Endovascular Graft, Aortic Aneurysm Treatment", "medical_specialty_description": "Unknown", "regulation_number": "", "device_class": "3", "registration_number": [ "3004497303", "2011171", "1054811", "3012102437", "1721686", "2017233", "3016521833", "3005562917", "9710641", "3002808486", "1219313", "9617601", "2247858", "3005580113", "3003678543", "9616099", "3009526575", "2953200", "1721676", "3006131984", "3007738736", "3013164176", "3008307705", "9680271", "2030624", "3002807314", "3008011247", "3009380063", "3011324393", "3007284313", "1820334", "9680654", "3011063223", "9612164" ], "fei_number": [ "3003259710", "3004497303", "2011171", "3003565456", "3012102437", "1721686", "2017233", "3016521833", "3005562917", "3002808486", "1000114185", "1219313", "3003528016", "3005580113", "3003678543", "3002534070", "3009526575", "1721676", "3006131984", "3007738736", "3013164176", "3002806434", "3008307705", "3000206435", "3002807314", "3008011247", "3009380063", "3011324393", "3001452571", "1000135961", "3007530363", "1820334", "3007284313", "3011063223" ] } } ] }