{ "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": "219885", "product_res_number": "Z-2653-2026", "event_date_initiated": "2026-04-23", "event_date_posted": "2026-07-02", "recall_status": "Open, Classified", "res_event_number": "98819", "product_code": "BTO", "k_numbers": [ "K843730" ], "product_description": "Covidien Shiley Disposable Decannulation Plug\nREF\nDDCP\nUDI-DI code: 10884522004060\n\nProduct Codes that include the Covidien Shiley Disposable Decannulation Plug are:\nProduct Number / UDI-DI code\n4DCFN 10884522006576\n4DCFS 10884522006583\n4DFEN 10884522006606\n6DCFN 10884522006613\n6DCFS 10884522006620\n6DFEN 10884522006644\n8DCFN 10884522006651\n8DCFS 40884522006690\n8DFEN 10884522006675\n10DCFN 20884522006535\n10DCFS 10884522006545\n10DFEN 10884522006569\n\nThe Shiley Disposable Decannulation Plug (DDCP) is a universal size and fits any size DCFS, DCFN, DFEN tracheostomy tube. The red DDCP snaplock connector is used to occlude the proximal end of the outer cannula on the Shiley Tracheostomy Tubes. Refer to Table 1 for model types. The DDCP blocks airflow through the tube and directs breathing through the mouth and nose. The Shiley Tracheostomy Tube and the accessory products are intended for use in providing tracheal access for airway management.", "code_info": "Product Number: DDCP\nUDI-DI code: 10884522004060\n\nThe below product numbers and UDI-DI codes that DDCP are:\n4DCFN / 10884522006576\n4DCFS / 10884522006583\n4DFEN / 10884522006606\n6DCFN / 10884522006613\n6DCFS / 10884522006620\n6DFEN / 10884522006644\n8DCFN / 10884522006651\n8DCFS / 40884522006690\n8DFEN / 10884522006675\n10DCFN / 20884522006535\n10DCFS / 10884522006545\n10DFEN / 10884522006569", "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 product labeling incorrectly including the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate as the product includes 30 to 35% DEHP.", "root_cause_description": "Labeling Change Control", "action": "On 04/23/2026, an \"Urgent Medical Device Correction\" letter was mail/email to customers informing them that the labeling for all lots of Covidien Shiley\" disposable decannulation plugs incorrectly includes the symbol indicating non-DEHP (Bis(2-ethylhexyl) phthalate). The seal of this product includes 30 to 35% DEHP.\n\nCustomers are instructed to:\n-No additional action is required by clinicians for the care or follow-up of patients who are using or have used Covidien Shiley\" disposable decannulation plugs.\n-Customers can continue to use the Covidien Shiley\" disposable decannulation plugs.\n-Post this notice in all care environments where the affected products are used to maintain awareness to this labeling issue.\n-Share this notice with all relevant personnel within their organization, and with any organization to which the affected product has been transferred or distributed.\n-Complete and return the enclosed Customer Confirmation Form to rs.gmbmitgfca@medtronic.comeven if you do not have unused inventory.\n\nAny questions regarding this communication, contact Medtronic Representative or Customer Service at 800-962-9888.", "product_quantity": "293,659 devices", "distribution_pattern": "U.S. Nationwide distribution including in the states and territories of AK, AL, AR, AZ, CA, CO, CT, DC, 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, PR, RI SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and Virgin Islands. The countries of Albania, Andorra, Argentina, Australia, Austria, Belgium, Bhutan, Canada, Canary Islands, Chile, Colombia, Costa Rica, Croatia, Cyprus, Czech Republic, Denmark, Dominican Republic, Finland, France, Georgia, Germany, Greece, Guadeloupe, Guyana, Hungary, Ireland, Israel, Italy, Japan, Kazakhstan, Kuwait, Latvia, Lithuania, Luxembourg, Martinique, Mexico, Netherlands, New Caledonia, New Zealand, North Macedonia, Norway, Oman, Paraguay, Peru, Poland, Portugal, Qatar, Reunion, Romania, Saudi Arabia, Slovakia, South Africa, Spain, Sweden, Switzerland, Togo, Trinidad And Tobago, Turkey, Uganda, United Arab Emirates, Uruguay.", "openfda": { "k_number": [ "K865061", "K822811", "K924193", "K841546", "K960205", "K042684", "K861645", "K842415", "K843785", "K820099", "K831720", "K823291", "K893866", "K833832", "K852272", "K841266", "K945406", "K874742", "K802916", "K790437", "K100480", "K895130", "K120079", "K830509", "K810106", "K810321", "K896798", "K853051", "K060945", "K924194", "K862909", "K952416", "K853511", "K882430", "K761258", "K902281", "K840539", "K031553", "K884730", "K781729", "K822440", "K890342", "K242921", "K840925", "K834179", "K850446", "K884015", "K941470", "K192511", "K870181", "K894096", "K901079", "K873499", "K030570", "K922749", "K880317", "K880614", "K832498", "K811447", "K854252", "K831511", "K903730", "K843730", "K872486", "K790930", "K923834", "K770218", "K853419", "K761190", "K051587", "K073702", "K920604", "K791044", "K871199", "K801931", "K021764", "K173384", "K810436", "K901920", "K880247", "K050379", "K912469", "K101721", "K851462", "K945407", "K850445", "K885139", "K100950", "K874450", "K862167", "K962240", "K914743", "K100283", "K862267", "K843729", "K901078", "K792069", "K860176", "K900548", "K955461", "K801379", "K855130", "K233713", "K862436", "K880316", "K981080", "K850456", "K884427", "K822295", "K030381", "K772138", "K953559", "K924191", "K895162", "K925249", "K921281", "K983000", "K832466", "K912124", "K920281", "K924195", "K062104", "K852413", "K083031", "K851016", "K811033", "K810978", "K810575" ], "device_name": "Tube, Tracheostomy (W/Wo Connector)", "medical_specialty_description": "Anesthesiology", "regulation_number": "868.5800", "device_class": "2", "registration_number": [ "3023294726", "3031233007", "2024841", "1220850", "3002808022", "3009887154", "3011137372", "2521453", "2936999", "9680661", "9612030", "3013557562", "3007740622", "3010131137", "3013298431", "2518436", "1423537", "3012542015", "3015997711", "3027579175", "1820334", "3003418325", "3012104670", "3012494290", "1832562", "3016904853", "9681384", "3010400865", "9616567", "3018094310", "3041276591", "1526534", "3013188547", "1319639", "3043226252", "3005034064", "2511556", "3002907620", "8020889", "3009039068", "3005609751", "8010485", "2025816", "1219795", "3030626857", "1825146", "3016678045", "1526863", "1314417", "1721676", "8010939", "1721686", "2032112", "2029015", "9617604", "3014461810", "3030447506", "2219920", "3001124136", "3014579161", "3010419931", "3011237704", "1836161", "3010041511", "3005941719", "3008132398", "3004365956", "1058584", "1928237", "1921846", "3003898360", "3040279832", "3011481350", "3021632375", "3014479313" ], "fei_number": [ "3023294726", "3031233007", "2024841", "1220850", "3002808022", "3009887154", "3002806934", "2521453", "2936999", "3013557562", "3007740622", "3010131137", "3005747797", "3013298431", "2518436", "3015997711", "3012542015", "3027579175", "3002750084", "3002808440", "1820334", "3003361161", "3003418325", "3012104670", "3012494290", "1832562", "1000219637", "3016904853", "3002963732", "3010400865", "3018094310", "3041276591", "1526534", "3013188547", "3002807091", "3002808696", "3043226252", "3005034064", "3002807626", "3002907620", "2511556", "3009039068", "3003382061", "3005609751", "2025816", "1219795", "3030626857", "1000138054", "1825146", "3016678045", "1526863", "1000160458", "1721676", "1314417", "1721686", "3002558692", "3014461810", "3030447506", "2219920", "3001124136", "3001236905", "3014579161", "3010419931", "3011237704", "3003076831", "3010041511", "3002807111", "1928237", "3004365956", "1921846", "3003898360", "3040279832", "3011481350", "3021632375", "3014479313" ] } } ] }