{ "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": "111929", "product_res_number": "Z-0057-2013", "event_date_initiated": "2012-08-03", "event_date_posted": "2012-10-13", "recall_status": "Terminated", "event_date_terminated": "2013-07-12", "res_event_number": "62879", "product_code": "GDW", "k_numbers": [ "K030411", "K030925", "K051301", "K991030" ], "product_description": "Hemorrhoidal Circular Stapler and Accessories 33mm \n\nProduct Usage: \n\nThe PROXIMATE HCS Hemorrhoidal Circular Staplers, (PPH01 and PPH03), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculo mucosal tissue. The TRANSTARTM CIRCULAR STAPLER, (STR10), and accessories have application for general surgical treatment of anorectal wall defects by means of transanal stapling and resection of mucosal and musculomucosal tissue.", "code_info": "PPH01: 68 lots; 19,030 pieces; Expiration date April 2016 -June 2017;  PPH03: 494 lots; 144,963 pieces; Expiration date March 2016 - June 2017;  STR10: 3 lots; 432 pieces; Expiration date Sept 2016 - Oct 2016", "firm_fei_number": "1527736", "recalling_firm": "Ethicon Endo-Surgery Inc", "address_1": "4545 Creek Rd", "city": "Cincinnati", "state": "OH", "postal_code": "45242-2803", "additional_info_contact": "Thomas A. Morris\n513-337-7000", "reason_for_recall": "Ethicon Endo-Surgery initiated this voluntary global recall for specific production lots of PROXIMATE PPH Hemorrhoidal Circular Stapler and Accessories 33mm (PPH01 and PPH03) and Transtar Circular Stapler Procedure Set (STR10) due to difficulty firing the device which may result in incomplete firing stroke that may result in an incomplete staple formation.", "root_cause_description": "Process change control", "action": "Ethicon Endo-Surgery sent an Urgent Device Recall letter dated August 3, 2012 via overnight, Federal Express UPS to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to examine inventory immediately, discontinue use, quarantine the material and return per the instructions provided. Customers were advised to complete the Business Reply Form (BRF) and fax it to Stericycle at 1-888-628-0733 within 3 business days, even if you do not have affected product. The letter states that Ethicon Endo-Surgery will issue credit for recalled products returned by November 5, 2012. Any product returned after November 5, 2012 will not be eligible for credit. For clinical or product support call 1-800-873-3636, option 6 or contact your local sales representative and reference Event 7283.", "product_quantity": "157,881 devices", "distribution_pattern": "Worldwide Distribution - US (nationwide) in the states of: AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY and the countries of: ARGENTINA, AUSTRALIA, BAHRAIN, BELGIUM, BRAZIL, CHILE, CHINA, COLOMBIA, COSTA RICA, CYPRUS, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GREECE, GUATEMALA, HONG KONG, INDIA, INDONESIA, ISRAEL, ITALY, JAPAN, JORDAN, REPUBLIC OF KOREA, KUWAIT, LEBANON, MALAYSIA, MEXICO, NEPAL, NICARAGUA, PAKISTAN, PANAMA, PARAGUAY, PERU, PHILIPPINES, PUERTO RICO, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, URUGUAY, VENEZUELA, VIETNAM, and YEMEN. There was one Canadian consignee and 43 U.S. Government consignees.", "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", "K100723", "K211458", "K151163", "K120268", "K181668", "K202507", "K083519", "K150026", "K900055", "K151659", "K152618", "K123109", "K192330", "K201280", "K133499", "K003277", "K801154", "K120373", "K172960", "K101444", "K073001", "K160176", "K103672", "K202864", "K111111", "K143129", "K014286", "K200320", "K140609", "K241630", "K970817", "K040024", "K192566", "K083527", "K890447", "K201934", "K102291", "K130653", "K132472", "K090159", "K130717", "K110728", "K141097", "K991030", "K032696", "K024275", "K121510", "K081826", "K061784", 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