{ "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": "167339", "product_res_number": "Z-0070-2019", "event_date_initiated": "2018-08-17", "event_date_created": "2018-10-04", "recall_status": "Terminated", "event_date_terminated": "2020-04-10", "res_event_number": "81043", "product_code": "GAG", "k_numbers": [ "K172361" ], "product_description": "EEA Circular Stapler with Tri-Staple Technology, Part No. TRIEEA28MT\tTRIEEA28XT\tTRIEEA31MT\tTRIEEA31XT\n\nProduct Usage: The EEA Circular Stapler with Tri-Staple Technology places a circular, triple staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis.", "code_info": "P8A0976X P8A0977X P8A0978X P8A0979X P8A0980X P8A0981X P8B1538X P8B1539X P8B1540X P8B1541X P8B1542X P8C0032X P8C0033X P8C1177X P8C1178X P8C1179X P8C1180X P8C1181X P8C1183X P8D1405X P8D1406X P8D1407X P8D1408X P8D1409X P8D1410X P8D1411X P8E1211X P8E1212X P8E1213X P8E1214X P8E1215X P8E1216X P8E1217X P8E1304X P8E1305X", "firm_fei_number": "1282497", "recalling_firm": "COVIDIEN LLC", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "Ms. Angela Pietrosimone\n203-492-8153", "reason_for_recall": "The firm identified the potential for a device to have an incorrect tissue gap. Use of a device with an incorrect tissue gap may result in incomplete staple formation and/or the inability to remove the device from tissue following application potentially leading to bleeding, anastomotic leak or tissue trauma. There have been no reports of serious injury related to this issue.", "root_cause_description": "Process design", "action": "All U.S. consignees were notified via Federal Express or certified mail\non August 17, 2018. The letter informs customers of the potential\nfor use of a device to have an incorrect tissue gap.\n\nRequired Actions:\n1. Please quarantine and discontinue use of the affected item code and lots listed above.\n\n2. Please return affected product. All unused products from the affected item codes and lots must be returned. If you purchased directly from Medtronic, return all inventory of the affected lots to Medtronic (Covidien), 195 McDermott\nRoad, North Haven, CT 06473, Attention: Field Returns Department. If you purchased from a distributor, complete all fields on the form and contact your distributor directly to arrange for return of product.\n\n3. If you have distributed EEA\" staplers with Tri-Staple\" technology listed above, please promptly forward the information from this letter to those recipients.\n\n4. Complete the Recalled Product Return Form even if you do not have inventory.\n\nIf you have any questions regarding this communication, please contact your Medtronic representative or Customer Service at 800-962-9888, option 2.", "product_quantity": "1,902", "distribution_pattern": "Worldwide Distribution - US Nationwide in the states of CA, FL, IL, NC, NY, UT. and the countries of Austria, Belgium, Denmark, Finland, France, Germany, Iceland, Italy, Latvia, Netherlands, Norway, Poland, Portugal, Reunion, Spain, Sweden, Switzerland, and United Kingdom.", "openfda": { "k_number": [ "K240881", "K840177", "K232126", "K970079", "K934188", "K851121", "K213633", "K243596", "K851258", "K830741", "K221629", "K862772", "K926127", "K771177", "K934105", "K834138", "K241629", "K811030", "K251482", "K802611", "K760733", "K813170", "K844417", "K771619", "K892927", "K933901", "K803038", "K820811", "K840178", "K823776", "K760732", "K844628", "K850947", "K801445", "K253527", "K231934", "K771113", "K884404", "K821228", "K932476", "K962258", "K234039", "K231491" ], "registration_number": [ "3010432890", "2029015", "3013388519", "1058584", "3011529314", "1417592", "3015183635", "3042940623", "3014479313", "3012428834", "3010157088", "3016096100", "3013868968", "3017196117", "3013942591", "3015140199", "3011063460", "2647580", "3014264910", "2011171", "1721686", "3018094310", "3018052045", "2032112", "3005440795", "3011989923", "3004111573", "3009941480", "3014461810", "3005075853", "9681572", "1527736", "3012050423", "3010326740", "3007222388", "1018470", "3004450679", "1219930", "3005369776", "3030733800", "3015185328", "3017210488", "3012421607", "3005273623", "3021632375", "1422634", "3010373263", "3007205024", "3032391", "3010377594", "3014279513", "3008388437", "3021604067", "3017181414", "3010611926", "3010131137", "3016832577", "3022626486", "3015173212", "1061124", "3012998149", "1650907", "3013188547", "9680518", "9611283", "3009931872", "3006210673", "3009848807", "3018126215", "3024021261", "2244478", "1928237", "3001620590", "3015612252", "9710649", "3005012805", "3010885402", "3009380063", "2955842", "1222928", "3001675293", "3020331900", "3004638532" ], "fei_number": [ "3010432890", "1000219637", "3013388519", "3003263857", "3011529314", "1417592", "3015183635", "3042940623", "3014479313", "3012428834", "1000514656", "3010157088", "3016096100", "3013868968", "1000120613", "3017196117", "3013942591", "3015140199", "3011063460", "2647580", "3014264910", "2011171", "3003076831", "1721686", "3018094310", "3018052045", "3005440795", "3011989923", "3004111573", "1000136269", "3009941480", "3014461810", "3005075853", "1527736", "3012050423", "3010326740", "3007222388", "1018470", "3004450679", "3002681132", "1219930", "1000160458", "3005369776", "3030733800", "3015185328", "3003565435", "3017210488", "3012421607", "3005273623", "3021632375", "3005304066", "3010373263", "3008615487", "3007205024", "3010377594", "3014279513", "3008388437", "3021604067", "3017181414", "3010611926", "3010131137", "3016832577", "1000512168", "3022626486", "3015173212", "3012998149", "3013188547", "3009931872", "3006210673", "3009848807", "3002299608", "3018126215", "3024021261", "3002806816", "1928237", "3001620590", "3015612252", "3005012805", "3010885402", "3009380063", "3001675293", "3020331900", "3004638532" ], "device_name": "Stapler, Surgical", "medical_specialty_description": "General Hospital", "regulation_number": "878.4740", "device_class": "2" } } ] }