{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "184751", "product_res_number": "Z-0747-2021", "event_date_initiated": "2020-11-23", "event_date_created": "2020-12-29", "recall_status": "Completed", "res_event_number": "86886", "product_code": "GDW", "k_numbers": [ "K111825" ], "product_description": "Covidien TA Auto Suture Vascular Stapler with DST Series Technology\n30mm-V 3. Intended for abdominal, gynecological, pediatric and thoracic surgical procedures for resection or transection of tissue.\nItem Number: TA30V3S", "code_info": "Lot Numbers: P0B1142MY, P0C1515MY, P0E0634MY, P0E1353MY, P0C0492MY,P0D1454MYP0E1352MY,P0G0601Y, P0C0493MY  UDI: 10884521043145, 20884521043142", "firm_fei_number": "1282497", "recalling_firm": "Covidien Llc", "address_1": "15 Hampshire St", "city": "Mansfield", "state": "MA", "postal_code": "02048-1113", "additional_info_contact": "508-261-8000", "reason_for_recall": "May contain a damaged internal component which could impede staple deployment and result in incomplete staple formation and a non-functional staple line preventing adequate hemostasis, or leading to anastomotic leak, pneumothorax, tissue damage or other delayed secondary complications including infection, peritonitis, and sepsis", "root_cause_description": "Process control", "action": "Medtronic issued Urgent Medical Device Recall letter by letter delivered via Federal Express and/or certified mail beginning November 23, 2020. The letter states reason for recall, health risk and action to take:\n1. Please immediately quarantine and discontinue use of affected item codes with associated lot numbers listed above.\n2. Please return affected product as indicated below. All unused products from the affected item codes and associated lot numbers must be returned.\n3. If you have distributed the Covidien TA\" Auto Suture\" Vascular Stapler and Loading Unit\nwith DST Series\" Technology listed above, please promptly forward the information from this letter to those recipients.\n4. Complete the Recalled Product Return Form even if you do not have inventory\n\nWe request that you contact Medtronic if you experienced a quality problem or adverse event.\n Email Medtronic Post Market Vigilance at: rs.assurancequality@medtronic.com\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": "3255 units US; 3574 units OUS", "distribution_pattern": "Nationwide\nForeign: \nCanada,\nAlbania\nArmenia\nAustralia\nAustria\nBelarus\nBelgium\nBosnia And Herzegovina\nCyprus\nCzech Republic\nEgypt\nEstonia\nFrance\nGermany\nGreece\nHungary\nIceland\nIsrael\nItaly\nJapan\nJordan\nKorea\nKuwait\nLatvia\nLibyan Arab Jamahiriya\nLithuania\nMalaysia\nMartinique\nMorocco\nMyanmar, \nNetherlands\nNorway\nPakistan\nPoland\nRussian Federation\nSerbia\nSingapore\nSlovakia\nSpain\nSweden\nSwitzerland\nTaiwan\nTurkey\nUnited Arab Emirates\nUnited Kingdom\nViet Nam", "openfda": { 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