{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "148248", "product_res_number": "Z-0295-2017", "event_date_initiated": "2016-07-15", "event_date_posted": "2016-10-20", "recall_status": "Terminated", "event_date_terminated": "2017-02-28", "res_event_number": "74701", "product_code": "GDW", "k_numbers": [ "K111111" ], "product_description": "Endoscopic Articulating Linear Cutter, ATB35. Standard 35 MM.\nThe ENDOPATH ETS-Flex Endoscopic Articulating Linear Cutter has application in general, gynecologic, urologic, and thoracic surgery for transection, resection, and/or creation of anastomoses", "code_info": "N91L48, N91L49, N91R40, N91R41, N91U0W, N91U0X", "firm_fei_number": "1527736", "recalling_firm": "Ethicon Endo-Surgery Inc", "address_1": "4545 Creek Rd", "city": "Blue Ash", "state": "OH", "postal_code": "45242-2803", "additional_info_contact": "Mark Neurohr\n513-337-3582", "reason_for_recall": "Quality control identified a component issue where the pinion gear in the device could fail under extreme use cases. If this condition occurs, staples will be formed past the cut line and the device can be opened and removed from the patient. The firing stroke may be interrupted and the knife may not fully return to the home position potentially exposing the healthcare professional to a sharps injury.", "root_cause_description": "Device Design", "action": "Ethicon sent an Urgent Medical Device Recall letter dated July 15, 2016, to all affected consignees via UPS next day mail. The letter identified the product, the problem, and the action to be taken by the customer. Consignees were instructed to examine their inventory immediately and quarantine any affected product and return to ENDOPATH. If product subject to the recall was further distributed consignees were instructed to notify the other facility and arrange for return of the affected product. Customer were instructed to complete the Business Reply Form confirming receipt of this letter and fax to Stericycle at 1-888-228-5719 or email to ethicon5182@stericycle.com.\nCustomers with questions were instructed to contact the Ethicon Customer Support Center at 1-877-384-4266.\nFor questions regarding this recall call 513-337-3582.", "product_quantity": "105", "distribution_pattern": "Worldwide Distribution - US including AL, AR, AZ, CA, CO,CT, DC, FL,GA, IA,IL,KS,KY,LA,MA,MD, ME, MI,MN,MO, MS, MT,NC, ND, NH,NJ, NM, NV, NY, OH, RI, TN, TX, VA, VT, WA, WI and Internationally to Brazil and Canada.", "openfda": { "k_number": [ "K161137", "K983536", "K221003", "K062869", "K910192", "K041331", "K160521", "K131663", "K163698", "K210909", "K101378", "K201882", "K253657", "K190331", "K200420", "K020779", "K162947", "K123114", "K131511", "K131637", "K111825", "K181657", "K020343", "K140118", "K120179", "K023725", "K911252", "K182475", "K211811", "K913832", "K001895", "K983318", "K921051", 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