{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "194232", "product_res_number": "Z-1322-2022", "event_date_initiated": "2022-05-13", "event_date_created": "2022-07-01", "recall_status": "Open, Classified", "res_event_number": "90362", "product_code": "GAG", "product_description": "EEA Autosuture Circular Stapler with DST Series Technology, 25mm. Model Numbers EEA25, EEAXL25, EEA2535, and EEAXL2535.", "code_info": "UDI-DI 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"firm_fei_number": "1219930", "recalling_firm": "Covidien, LP", "address_1": "60 Middletown Ave", "city": "North Haven", "state": "CT", "postal_code": "06473-3908", "additional_info_contact": "Medtronic Customer Service\n203-492-5000", "reason_for_recall": "The affected staplers have the potential for the staple guide to not be securely attached to the instrument. The issue could cause the component to disengage and if disengaged, could allow the device to transect tissue without forming staples.", "root_cause_description": "Process change control", "action": "Beginning 13-MAY-2022 communications to all affected consignees began. In\nthe United States notifications are set via UPS 2-day delivery. \n\nCustomers should return all unused affected product in inventory to Medtronic.\n\nConsignees are asked to forward this notification to those who need to be\naware within the organization and to any location which the devices have\nbeen transferred.\nConsignees are asked to complete and return a confirmation certificate (or\nequivalent record) confirming they have received the notification.", "product_quantity": "433,560", "distribution_pattern": "Worldwide distribution - US Nationwide.", "openfda": { "k_number": [ "K760732", "K844417", "K934105", "K243596", "K231934", "K232126", "K892927", "K221629", "K830741", "K862772", "K760733", "K823776", "K771113", "K962258", "K932476", "K253527", "K933901", "K771619", "K213633", "K840178", "K851258", "K844628", "K241629", "K813170", "K850947", "K771177", "K851121", "K821228", "K970079", "K934188", "K234039", "K802611", "K884404", "K811030", "K801445", "K820811", "K926127", "K803038", "K834138", "K840177", "K240881", "K231491", "K251482" ], "registration_number": [ "3008388437", "3017181414", "3005440795", "3010326740", "3032391", "3015612252", "3014461810", "3007222388", "3010611926", "3014479313", "3015173212", "1650907", "3030733800", "3015140199", "3001675293", "9681572", "3009931872", "2029015", "3014264910", "3011063460", "3005012805", "3016096100", "1061124", "3018094310", "3021604067", "3042940623", "1018470", "3012421607", "3010432890", "9710649", "3009848807", "3004450679", "3010131137", "3015183635", "3022626486", "3018126215", "3018052045", "3012428834", "3017210488", "3005369776", "3017196117", "1422634", "2244478", "3005075853", "3016832577", "2647580", "1417592", "1928237", "3004111573", "9680518", "1527736", "1222928", "9611283", "3013942591", "3011529314", "3024021261", "3012050423", "3009380063", "3013188547", "3014279513", "3021632375", "3009941480", "3004638532", "3013388519", "3012998149", "1219930", "3005273623", "3010377594", "3010885402", "3006210673", "3010157088", "3011989923", "3007205024", "3010373263", "2955842", "3020331900", "3001620590", "3013868968", "2032112", "2011171", "1721686", "3015185328", "1058584" ], "fei_number": [ "3008388437", "3017181414", "3005440795", "3010326740", "3015612252", "3002806816", "3014461810", "3007222388", "3010611926", "3014479313", "3015173212", "3003076831", "3030733800", "3015140199", "3001675293", "3002681132", "3009931872", "3014264910", "3011063460", "1000512168", "1000120613", "3005012805", "3016096100", "3018094310", "3021604067", "3042940623", "1018470", "3012421607", "3010432890", "3009848807", "3004450679", "3010131137", "3015183635", "1000219637", "3022626486", "3005304066", "3018126215", "3003565435", "3018052045", "3012428834", "3017210488", "3005369776", "3017196117", "3005075853", "3016832577", "2647580", "1417592", "1928237", "3004111573", "3003263857", "1527736", "1000136269", "3013942591", "3011529314", "3024021261", "3012050423", "3008615487", "3009380063", "3013188547", "3014279513", "3021632375", "3009941480", "3004638532", "3013388519", "3012998149", "1219930", "3005273623", "3010377594", "3010885402", "1000514656", "3006210673", "3010157088", "3002299608", "3011989923", "3007205024", "3010373263", "1000160458", "3020331900", "3001620590", "3013868968", "2011171", "1721686", "3015185328" ], "device_name": "Stapler, Surgical", "medical_specialty_description": "General Hospital", "regulation_number": "878.4740", "device_class": "2" } } ] }