{ "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": 1 } }, "results": [ { "cfres_id": "219873", "product_res_number": "Z-2261-2026", "event_date_initiated": "2026-04-15", "event_date_posted": "2026-05-29", "recall_status": "Open, Classified", "res_event_number": "98813", "product_code": "JOH", "k_numbers": [ "K812302" ], "product_description": "COVIDIEN Shiley Tracheostomy Tube Cuffed with Inner Cannula REF 6FEN\nUDI-DI code: 60884522007028\n\nThe devices are intended for use in providing tracheal access for airway management. Shiley Tracheostomy Tubes are double cannula tracheostomy tubes with reusable\ninner cannulae (LPC, FEN, CFS, CFN, LGT) and twist-lock connectors. These Shiley\nTracheostomy Tubes have a radiopaque, biocompatible outer cannula constructed of\npolyvinyl chloride.", "code_info": "Product Number: 6FEN\nUDI-DI code: 60884522007028\nLot Number: 25H0868JZX", "firm_fei_number": "2936999", "recalling_firm": "Covidien LLC", "address_1": "6135 Gunbarrel Ave", "city": "Boulder", "state": "CO", "postal_code": "80301-3214", "additional_info_contact": "Technical and Clinical Support\n800-255-6774 Ext. 6", "reason_for_recall": "Due to customer complaint regarding incorrect display box labeling.", "root_cause_description": "Process control", "action": "On 04/15/2026, the firm sent via mail/email an \"Urgent Medical Device Recall\" Letter to customers informing them that due to a manufacturing process packaging error, correctly manufactured and labeled individual units of the Covidien Shiley\" cuffed fenestrated adult tracheostomy tube with reusable inner cannula were inadvertently placed into incorrect display boxes. A customer report indicating that the product display box is incorrectly labeled as item code 6CFN, which corresponds to cuffless devices. The correct item code is 6FEN, and it appears correctly on all other labeling, including the outer carton labels and device tray label.\n\nCustomers are instructed to:\n1. Quarantine all unused product from the affected lot of Covidien Shiley\" cuffed fenestrated adult tracheostomy tube with reusable inner cannula.\n2. Return all unused product from the affected lot in their inventory to Medtronic, as described in the Customer Confirmation Form.\n3. Share this notice with all relevant personnel within their organization, and with any organization to which the potentially affected product from the specified lot has been transferred or distributed.\n4. Complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.com even if they do not have unused inventory.\n\nFor questions - contact Medtronic Representative or Customer Service at 800-962-9888.", "product_quantity": "1,002", "distribution_pattern": "Worldwide - U.S.: Nationwide distribution in the state of TX and the countries of France, French, Polynesia, Italy, Pakistan, Poland, Portugal, Spain, and Taiwan.", "openfda": { "k_number": [ "K170720", "K914088", "K023918", "K931611", "K912967", "K894050", "K173912", "K955680", "K760453", "K031057", "K180034", "K925020", "K972546", "K955564", "K962078", "K041485", "K921733", "K043160", "K041044", "K072582", "K910362", "K924660", "K133173", "K972423", "K990905", "K072148", "K925288", "K971267", "K962714", "K897102", "K972385", "K123699", "K896547", "K962175", "K903435", "K885129", "K922665", "K812163", "K964056", "K122531", "K897059", "K933412", "K203362", "K945874", "K897005", "K193133", "K210833", "K970365", "K030787", "K945513", "K896548", "K913859", "K151404", "K914471", "K142298", "K172720", "K952700", "K193077", "K890194", "K051416", "K954661", "K182861", "K022212", "K894614", "K122235", "K944451", "K013728", "K093469", "K954749", "K936133", "K911080", "K122932", "K041348", "K040014", "K914183", "K960429", "K944178", "K924243", "K913270", "K932016", "K000964", "K011210", "K142296", "K150844", "K925438", "K961449", "K014102", "K930895", "K812302", "K081440", "K894613", "K003315", "K973829", "K133528", "K251313", "K955516", "K982128", "K903699", "K133597", "K963732", "K936224", "K962173", "K923878", "K980466", "K923156", "K083641", "K970811", "K100995", "K885130" ], "registration_number": [ "3031233007", "3012502601", "2024841", "3002808022", "3009887154", "3011137372", "3009518015", "2936999", "3008806809", "3013557562", "3006017180", "3014656749", "8040412", "3037918935", "3013298431", "3012542015", "3027579175", "1820334", "3008258694", "1219930", "3030446844", "3012494290", "3011987967", "3014054118", "9681384", "3018094310", "3043337628", "1526534", "3013188547", "1219611", "3008278458", "1319639", "3043226252", "3002807561", "8020889", "3009039068", "3002807314", "3030733800", "8010485", "2025816", "1219795", "3030626857", "3021632375", "3016678045", "3017210488", "1314417", "3009771213", "8010939", "1721686", "8032044", "2032112", "3012421607", "9617604", "3014461810", "3010220595", "3030447506", "2219920", "3014579161", "8030673", "3011689956", "3011237704", "3010041511", "3005941719", "3008132398", "3004365956", "1058584", "3004551550", "3011088743", "1928237", "3007502289", "2011171", "3003761012", "3014479313", "2648727" ], "fei_number": [ "3031233007", "3012502601", "2024841", "3002808022", "3009887154", "3009518015", "2936999", "3008806809", "3013557562", "3006017180", "3014656749", "3037918935", "3005747797", "3013298431", "3012542015", "3027579175", "3002808440", "1820334", "3008258694", "1219930", "3003361161", "3002806269", "3030446844", "3012494290", "3011987967", "1000219637", "3014054118", "3018094310", "3043337628", "1526534", "3013188547", "1219611", "3002807091", "3008278458", "3043226252", "3002807626", "3002807561", "3009039068", "3003382061", "3002807314", "3030733800", "2025816", "1219795", "3030626857", "1000138054", "3021632375", "3016678045", "3017210488", "1314417", "3009771213", "1721686", "3002558692", "3012421607", "3009271244", "3014461810", "3010220595", "3030447506", "2219920", "3014579161", "3011689956", "3011237704", "3003076831", "3010041511", "3002807111", "3004213967", "3004365956", "1928237", "3004551550", "3011088743", "3007502289", "2011171", "3003761012", "3014479313", "2648727" ], "device_name": "Tube Tracheostomy And Tube Cuff", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2" } } ] }