{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "216634", "product_res_number": "Z-0434-2026", "event_date_initiated": "2025-10-02", "event_date_posted": "2025-11-13", "recall_status": "Open, Classified", "res_event_number": "97814", "product_code": "HCG", "k_numbers": [ "K220040" ], "product_description": "CEREPAK Detachable Coil System - Name/REF:\nUNIFORM 2MM X 2.5 CM/FCX100202,\nUNIFORM 2.5MM X 3.3 CM/FCX100253,\nUNIFORM 3MM X 5.4 CM/FCX100305,\nUNIFORM 3.5MM X 6.6 CM/FCX100356,\nUNIFORM 4MM X 7.5 CM/FCX100407,\nUNIFORM 4MM X 11.5 CM/FCX100412,\nUNIFORM 5MM X 9.7 CM/FCX100509,\nUNIFORM 5MM X 17 CM/FCX100517,\nUNIFORM 6MM X 11.9 CM/FCX100611,\nUNIFORM 6MM X 26 CM/FCX100626,\nUNIFORM 7MM X 13.9 CM/FCX100713,\nUNIFORM 7MM X 30 CM/FCX100730,\nUNIFORM 8MM X 16.1 CM/FCX100816,\nUNIFORM 8MM X 29 CM/FCX100829,\nUNIFORM 3D 2MM X 2.5 CM/FCX140225,\nUNIFORM 3D 3MM X 3 CM/FCX140303,\nUNIFORM 3D 3MM X 4 CM/FCX140304,\nUNIFORM 3D 3MM X 6 CM/FCX140306,\nUNIFORM 3D 4MM X 6 CM/FCX140406,\nUNIFORM 3D 4MM X 8 CM/FCX140408,\nUNIFORM 3D 4MM X 4.5 CM/FCX140445,\nUNIFORM 3D 5MM X 7 CM/FCX140507,\nUNIFORM 3D 5MM X 12 CM/FCX140512,\nUNIFORM 3D 6MM X 9 CM/FCX140609,\nUNIFORM 3D 6MM X 15 CM/FCX140615,\nUNIFORM 3D 7MM X 11 CM/FCX140711,\nUNIFORM 3D 7MM X 17 CM/FCX140717,\nUNIFORM 3D 8MM X 12 CM/FCX140812,\nUNIFORM 3D 8MM X 20 CM/FCX140820,\nUNIFORM 3D 9MM X 14 CM/FCX140914,\nUNIFORM 3D 9MM X 22 CM/FCX140922,\nUNIFORM 3D 10MM X 16 CM/FCX141016,\nUNIFORM 3D 10MM X 25 CM/FCX141025,\nUNIFORM 3D 11MM X 18 CM/FCX141118,\nUNIFORM 3D 11MM X 27 CM/FCX141127,\nUNIFORM 3D 12MM X 19 CM/FCX141219,\nUNIFORM 3D 12MM X 30 CM/FCX141230,\nUNIFORM XL 5MM X 10 CM/FCX180510,\nUNIFORM XL 6MM X 12.2 CM/FCX180612,\nUNIFORM XL 7MM X 14.3 CM/FCX180714,\nUNIFORM XL 8MM X 13.6 CM/FCX180813,\nUNIFORM XL 8MM X 30 CM/FCX180830,\nUNIFORM XL 9MM X 15.3 CM/FCX180915,\nUNIFORM XL 9MM X 33 CM/FCX180933,\nUNIFORM XL 10MM X 17.1 CM/FCX181017,\nUNIFORM XL 10MM X 34 CM/FCX181034,\nUNIFORM XL 11MM X 18.9 CM/FCX181118,\nUNIFORM XL 11MM X 37 CM/FCX181137,\nUNIFORM XL 12MM X 20.7 CM/FCX181220,\nUNIFORM XL 12MM X 40 CM/FCX181240,\nUNIFORM XL 13MM X 43 CM/FCX181343,\nUNIFORM XL 14MM X 47 CM/FCX181447,\nUNIFORM XL 15MM X 50 CM/FCX181550,\nUNIFORM XL 16MM X 47 CM/FCX181647,\nUNIFORM XL 17MM X 50 CM/FCX181750,\nUNIFORM XL 18MM X 46 CM/FCX181846,\nUNIFORM XL 19MM X 50 CM/FCX181950,\nUNIFORM XL 20MM X 50 CM/FCX182050,\nFREEFORM MINI 1MM X 1CM/MCR091010,\nFREEFORM MINI 1MM X 1.5CM/MCR091015,\nFREEFORM MINI 1MM X 2CM/MCR091020,\nFREEFORM MINI 1MM X 2.5CM/MCR091025,\nFREEFORM MINI 1MM X 3CM/MCR091030,\nFREEFORM MINI 1MM X 4CM/MCR091040,\nFREEFORM MINI 1.5MM X 2CM/MCR091520,\nFREEFORM MINI 1.5MM X 2.5CM/MCR091525,\nFREEFORM MINI 1.5MM X 3CM/MCR091530,\nFREEFORM MINI 1.5MM X 4CM/MCR091540,\nFREEFORM MINI 2MM X 2CM/MCR092020,\nFREEFORM MINI 2MM X 3CM/MCR092030,\nFREEFORM MINI 2MM X 4CM/MCR092040,\nFREEFORM MINI 2MM X 6CM/MCR092060,\nFREEFORM MINI 2.5MM X 3.5CM/MCR092535,\nFREEFORM MINI 2.5MM X 4.5CM/MCR092545,\nFREEFORM MINI 2.5MM X 5.5CM/MCR092555,\nFREEFORM MINI 3MM X 4CM/MCR093040,\nFREEFORM MINI 3MM X 6CM/MCR093060,\nFREEFORM MINI 3MM X 8CM/MCR093080,\nFREEFORM 2MM X 2 CM/SCR120202,\nFREEFORM 3MM X 6 CM/SCR120306,\nFREEFORM 3MM X 8 CM/SCR120308,\nFREEFORM 4MM X 7 CM/SCR120407,\nFREEFORM 4MM X 10 CM/SCR120410,\nFREEFORM 4MM X 12 CM/SCR120412,\nFREEFORM 5MM X 10 CM/SCR120510,\nFREEFORM 5MM X 15 CM/SCR120515,\nFREEFORM 6MM X 10 CM/SCR120610,\nFREEFORM 6MM X 15 CM/SCR120615,\nFREEFORM 6MM X 20 CM/SCR120620,\nFREEFORM 7MM X 15 CM/SCR120715,\nFREEFORM 7MM X 21 CM/SCR120721,\nFREEFORM 8MM X 15 CM/SCR120815,\nFREEFORM 8MM X 24 CM/SCR120824,\nFREEFORM 9MM X 25 CM/SCR120925,\nFREEFORM 10MM X 30 CM/SCR121030,\nFREEFORM 12MM X 30 CM/SCR121230,\nFREEFORM 2.5MM X 5 CM/SCR122505,\nFREEFORM 2.5MM X 3.5 CM/SCR122535,\nFREEFORM 3.5MM X 9 CM/SCR123509,\nFREEFORM 3.5MM X 7.5 CM/SCR123575,\nHELIFORM SOFT 1.5MM X 4 CM/SHD100154,\nHELIFORM SOFT 2MM X 8 CM/SHD100208,\nHELIFORM SOFT 2.5MM X 10 CM/SHD100250,\nHELIFORM SOFT 2.5MM X 8 CM/SHD100258,\nHELIFORM SOFT 3MM X 8 CM/SHD100308,\nHELIFORM SOFT 3MM X 10 CM/SHD100310,\nHELIFORM SOFT 4MM X 8 CM/SHD100408,\nHELIFORM SOFT 4MM X 10 CM/\tSHD100410,\nHELIFORM SOFT 5MM X 10 CM/\tSHD100510,\nHELIFORM SOFT 5MM X 15 CM/\tSHD100515,\nHELIFORM SOFT 6MM X 12 CM/\tSHD100612,\nHELIFORM SOFT 6MM X 16 CM/\tSHD100616,\nHELIFORM SOFT 7MM X 16 CM/\tSHD100716,\nHELIFORM SOFT 7MM X 20 CM/\tSHD100720,\nHELIFORM SOFT 8MM", "code_info": "All devices/lots manufactured prior to and including August 2025 are affected.\nREF/UDI-DI:\nFCX100202/10886704083986,\nFCX100253/10886704083979,\nFCX100305/10886704083962,\nFCX100356/10886704083993,\nFCX100407/10886704084013,\nFCX100412/10886704084006,\nFCX100509/10886704084037,\nFCX100517/10886704084020,\nFCX100611/10886704084044,\nFCX100626/10886704084051,\nFCX100713/10886704084068,\nFCX100730/10886704084075,\nFCX100816/10886704084082,\nFCX100829/10886704084099,\nFCX140225/10886704084167,\nFCX140303/10886704084174,\nFCX140304/10886704084181,\nFCX140306/10886704084198,\nFCX140406/10886704084211,\nFCX140408/10886704084228,\nFCX140445/10886704084204,\nFCX140507/10886704084242,\nFCX140512/10886704084235,\nFCX140609/10886704084266,\nFCX140615/10886704084259,\nFCX140711/10886704084273,\nFCX140717/10886704084280,\nFCX140812/10886704084297,\nFCX140820/10886704084303,\nFCX140914/10886704084310,\nFCX140922/10886704084327,\nFCX141016/10886704084105,\nFCX141025/10886704084112,\nFCX141118/10886704084129,\nFCX141127/10886704084136,\nFCX141219/10886704084143,\nFCX141230/10886704084150,\nFCX180510/10886704084464,\nFCX180612/10886704084471,\nFCX180714/10886704084488,\nFCX180813/10886704084495,\nFCX180830/10886704084501,\nFCX180915/10886704084518,\nFCX180933/10886704084525,\nFCX181017/10886704084334,\nFCX181034/10886704084341,\nFCX181118/10886704084358,\nFCX181137/10886704084365,\nFCX181220/10886704084372,\nFCX181240/10886704084389,\nFCX181343/10886704084396,\nFCX181447/10886704084402,\nFCX181550/10886704084419,\nFCX181647/10886704084426,\nFCX181750/10886704084433,\nFCX181846/10886704084440,\nFCX181950/10886704084457,\nFCX182050/10886704082880,\nMCR091010/10886704082897,\nMCR091015/10886704082903,\nMCR091020/10886704082910,\nMCR091025/10886704082927,\nMCR091030/10886704082934,\nMCR091040/10886704082941,\nMCR091520/10886704082958,\nMCR091525/10886704082965,\nMCR091530/10886704082972,\nMCR091540/10886704082989,\nMCR092020/10886704084778,\nMCR092030/10886704082996,\nMCR092040/10886704083009,\nMCR092060/10886704083016,\nMCR092535/10886704083023,\nMCR092545/10886704083030,\nMCR092555/10886704083047,\nMCR093040/10886704083054,\nMCR093060/10886704083061,\nMCR093080/10886704083078,\nSCR120202/10886704083085,\nSCR120306/10886704083092,\nSCR120308/10886704083108,\nSCR120407/10886704083115,\nSCR120410/10886704083122,\nSCR120412/10886704083139,\nSCR120510/10886704083146,\nSCR120515/10886704083153,\nSCR120610/10886704083160,\nSCR120615/10886704083177,\nSCR120620/10886704083184,\nSCR120715/10886704083191,\nSCR120721/10886704083207,\nSCR120815/10886704083214,\nSCR120824/10886704083221,\nSCR120925/10886704083238,\nSCR121030/10886704083245,\nSCR121230/10886704083252,\nSCR122505/10886704083269,\nSCR122535/10886704083276,\nSCR123509/10886704083283,\nSCR123575/10886704083290,\nSHD100154/10886704083306,\nSHD100208/10886704083313,\nSHD100250/10886704083320,\nSHD100258/10886704083337,\nSHD100308/10886704083344,\nSHD100310/10886704083351,\nSHD100408/10886704083368,\nSHD100410/10886704083375,\nSHD100510/10886704083382,\nSHD100515/10886704083399,\nSHD100612/10886704083405,\nSHD100616/10886704083412,\nSHD100716/10886704083429,\nSHD100720/10886704083436,\nSHD100820/10886704083443,\nSHD100925/10886704083450,\nSHD180312/10886704083467,\nSHD180415/10886704083474,\nSHD180520/10886704083481,\nSHD180625/10886704083498,\nSHD180733/10886704083504,\nSHD180835/10886704083511,\nSHD180935/10886704083528,\nSHD181040/10886704083535,\nSHD181242/10886704083542,\nSHD181445/10886704083559,\nSHD181650/10886704083566,\nSHD181855/10886704083573,\nSHD182060/10886704083580,\nSHD182260/10886704083597,\nSHD182460/10886704083603,\nXCR120201/10886704083610,\nXCR120202/10886704083627,\nXCR120304/10886704083634,\nXCR120306/10886704083641,\nXCR120308/10886704083658,\nXCR120406/10886704083665,\nXCR120408/10886704083672,\nXCR120410/10886704083689,\nXCR120510/10886704083696,\nXCR120515/10886704083702,\nXCR120610/10886704083719,\nXCR120620/10886704083726,\nXCR122505/10886704083733,\nXCR122525/10886704083740,\nXCR122535/10886704083757,\nXCR123505/10886704083764,\nXCR123509/10886704083771,\nXCR123575/10886704083788,\nXHD100151/10886704083795,\nXHD100152/10886704083801,\nXHD100153/10886704083818,\nXHD100201/10886704083825,\nXHD100202/10886704083832,\nXHD100203/10886704083849,\nXHD100204/10886704083856,\nXHD100206/10886704083863,\nXHD100254/10886704083870,\nXHD100256/10886704083887,\nXHD100304/10886704083894,\nXHD100306/10886704083900,\nXHD100406/10886704083917,\nXHD100408/10886704083924,\nXHE120204/10886704083931,\nXHE120206/10886704083948,\nXHE120208/10886704083955,\nMDH1/10886704084600", "firm_fei_number": "3007628272", "recalling_firm": "Cerenovus Inc", "address_1": "6303 Blue Lagoon Dr Ste 315 6303 Blue Lagoon Dr", "address_2": "Ste 315", "city": "Miami", "state": "FL", "postal_code": "33126-6068", "additional_info_contact": "Samuel Shimp\n305-265-6811", "reason_for_recall": "Detachable coils system may fail to detach, which could result in hemorrhagic and ischemic stroke, procedural delays, or the need for additional surgical intervention.", "root_cause_description": "Under Investigation by firm", "action": "On 10/2/2025, Johnson & Johnson Med Tech mailed \"URGENT: MEDICAL DEVICE RECALL (REMOVAL)\" notices dated 10/1/2025 to customers who were asked to do the following:\n\n1. Immediately stop using the affected devices.\n2. Identify and segregate all affected devices that are in inventory / consignment at your facility.\n3. Firm sales representative will coordinate the removal of the product from your facility and will coordinate the credit, as applicable, for any customer-owned inventory.\n4. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed.\n5. If any product subject to this recall has been forwarded to another facility, contact that facility, provide a copy of this letter and notify J&J sales representative.\n6. If the product has been successfully implanted, there is no additional action needed. \n7. Complete and return the attached Business Reply Form in Attachment 2 to:\nOneMD-Field-Actions@its.jnj.com. Please return the BRF even if you do not have product subject to this recall.\n8. Keep this notice visibly posted for awareness until all product subject to this recall have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall and keep a copy for your records.\n\nIf you have additional questions regarding this medical device recall (removal), please contact firm at OneMD-Field-Actions@its.jnj.com.", "product_quantity": "12004", "distribution_pattern": "US Nationwide distribution: CO, GA, MD, UT, OK, WI, MA, TN, SC, TX, CA, WV, LA, IL, NY, IA, AZ, AL, CT, WA, OH, ME, DC, FL, SD, KY, NJ, DE, NC, PA, MI, MO, VA, NH, NV and OR.", "openfda": { "k_number": [ "K060747", "K093142", "K914866", "K102672", "K040694", "K002181", "K261772", "K172390", "K925523", "K012145", "K031049", "K161367", "K032542", "K010026", "K983483", "K112181", "K031168", "K014041", "K080967", "K022420", "K142513", "K242582", "K150319", "K073419", "K082324", "K073442", "K032707", "K030963", "K090001", "K090891", "K131475", "K100454", "K901721", "K063254", "K203625", "K041649", "K230284", "K112226", "K180653", "K132317", "K030392", "K060625", "K140104", "K091641", "K001083", "K242154", "K960705", "K070656", "K083646", "K111451", "K032553", "K993417", "K254221", "K021494", "K103355", "K913312", "K963307", "K033372", "K053197", "K112385", "K021914", "K031578", "K161452", "K020033", "K251832", "K151572", "K151447", "K913556", "K252700", "K030475", "K171862", "K032497", "K093358", "K964021", "K093919", "K972881", "K173711", "K071246", "K260351", "K120330", "K891688", "K012985", "K141134", "K200030", "K000651", "K991139", "K211344", "K252694", "K153594", "K053548", "K123560", "K113457", "K203432", "K160096", "K052509", "K242243", "K171747", "K050700", "K103305", "K161429", "K042539", "K160832", "K071634", "K162999", "K900723", "K092666", "K133310", "K901337", "K050954", "K082739", "K031852", "K132952", "K094018", "K002056", "K032872", "K232955", "K223386", "K153658", "K911779", "K022735", "K062036", "K050543", "K113412", "K993415", "K080666", "K072173", "K090168", "K080379", "K944354", "K120274", "K063653", "K220040", "K951314", "K962503", "K233420", "K964367", "K142429", "K120686", "K032619", "K103008", "K991549", "K131948", "K871047", "K051425", "K001678", "K120908", "K022427", "K113822", "K961923", "K173614", "K093973", "K071962", "K053160", "K033761", "K080437", "K143218", "K192068", "K210638", "K051560", "K023089", "K212455", "K993418", "K042297", "K020434", "K070707", "K103758", "K123377", "K222533", "K132482", "K192955", "K920324", "K123338", "K042231", "K032590", "K925876", "K041551", "K951256", "K965174", "K120850", "K170852", "K033813", "K033836", "K082461", "K151760", "K162704", "K090357" ], "device_name": "Device, Neurovascular Embolization", "medical_specialty_description": "Neurology", "regulation_number": "882.5950", "device_class": "2", "registration_number": [ "", "3044156918", "3033589330", "1820334", "3008837339", "3013944123", "2030598", "3008307705", "3017961114", "3013556777", "3027595249", "3015453963", "1225687", "3012543881", "3000143502", "3010173425", "2134265", "2032364", "1043729", "3007738736", "3015550451", "3005168196", "3012931345", "3008853977", "9615728", "9614654", "3006950086", "3008824097", "3009380063", "3002807295", "3009761573", "3015615738", "3014162263", "3008114965", "2133641", "2022435", "1226348", "3031550970", "3014644549", "2126666", "2011171", "3012536737", "3016609702", "3010079067", "1220477", "3016245399", "2124215", "3010178296", "3013353964", "3015531723", "3015309643", "2029214", "3003524171", "3008881809", "2029275", "3013758550", "3008264254", "3016591327", "3016540856", "3007029079", "1721676", "9617601", "9616684", "3007628272" ], "fei_number": [ "", "3044156918", "3033589330", "1820334", "3002534070", "3008837339", "3013944123", "3008307705", "3002807036", "3017961114", "3013556777", "3027595249", "3015453963", "1000518731", "3012543881", "3000143502", "1043729", "3007738736", "3002095335", "3015550451", "3005168196", "3001451463", "3003323921", "3012931345", "3008853977", "3006950086", "3002913962", "3008824097", "3009380063", "3002807295", "3009761573", "3015615738", "3002947440", "3002808761", "3014162263", "3008114965", "2022435", "1000220862", "3031550970", "3000203466", "3014644549", "2126666", "2011171", "3012536737", "3016609702", "3010079067", "1220477", "3016245399", "2124215", "3013353964", "3015531723", "3015309643", "3002808904", "1000306431", "3008881809", "3003524171", "3013758550", "3008264254", "3016591327", "3016540856", "3007029079", "1721676", "3003110073", "3007628272" ] } } ] }