{ "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": "219266", "product_res_number": "Z-2552-2026", "event_date_initiated": "2026-04-06", "event_date_posted": "2026-06-24", "recall_status": "Open, Classified", "res_event_number": "98630", "product_code": "HCG", "k_numbers": [ "K212455" ], "product_description": "INZONE DETACHMENT SYSTEM, REF: M00345100950", "code_info": "UDI-DI: 04546540697950. Lots: WMP133638, WMP133871, WMP133872, WMP133988, WMP133989, WMP134016, WMP134132, WMP134133, WMP134234, WMP134235, WMP134255, WMP134256, WMP134380, WMP134381, WMP134432, WMP134433, WMP134518, WMP134519, WMP134609, WMP134610, WMP134794, WMP134795, WMP134939, WMP134940, WMP135187, WMP135243, WMP135302, WMP135314, WMP135354, WMP135355, WMP135387, WMP135417, WMP135473, WMP135475, WMP135491, WMP135492, WMP135623, WMP135720, WMP135727, WMP135807, WMP135865, WMP135897, WMP136084, WMP136107, WMP136190, WMP136200, WMP136611, WMP136642, WMP136736, WMP136748, WMP136852, WMP136894, WMP136985", "firm_fei_number": "3008853977", "recalling_firm": "Stryker Neurovascular", "address_1": "47900 Bayside Pkwy", "city": "Fremont", "state": "CA", "postal_code": "94538-6515", "additional_info_contact": "415-872-6400", "reason_for_recall": "Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended, which may necessitate medical intervention if the procedure must be completed with an alternative technique.", "root_cause_description": "Component design/selection", "action": "On 4/3/2026, recall notices were mailed to Supply Chain Management and Recall Coordinators who were asked to do the following:\n1) Segregate the affected devices in a secure location for return to recalling firm.\n2) If any of the subject devices have been distributed to other organizations, please forward a copy of this notice to the new users and provide contact details to recalling firm so new recipients can be informed appropriately.\n3) Maintain awareness of this communication internally until all required actions have been completed within your facility.\n4) Complete and return the Business Reply Form via email to nvfieldactions@stryker.com \n\nFor any additional information or questions, please contact nvfieldactions@stryker.com or US Customer Service: 1-855-91-NEURO (1-855-916-3876), Email: NVCustomerCare@stryker.com", "product_quantity": "44,937", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of PA, AZ, FL, CA, IL, AK, NY, MI, NJ, WI, SD, KY, AR, TX, AL, TN, MO, MA, IN, NE, WV, MT, CT, NC, VA, NV, CO, DC, DE, OH, ME, GA, WA, SC, GU, MN, OK, NH, MD, ND, UT, HI, OR, LA, MS, KS, NM, ID, IA, VT and the countries of ARGENTINA, AUSTRIA, BELGIUM, BRASIL, BULGARIA, CANADA, CANARY ISLANDS, CHILE, COLOMBIA, CROATIA, CZECH REPUBLIC, DENMARK, ESTONIA, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, HUNGARY, ICELAND, IRAN, IRELAND, ISRAEL, ITALIA, JAPAN, KOREA, LATVIA, LUXEMBOURG, MALAYSIA, MEXICO, NETHERLANDS, NORTHERN IRELAND, NORWAY, PHILIPPINES, POLAND, PORTUGAL, QATAR, ROMANIA, RUSSIA, SAUDI ARABIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SOUTH PACIFIC, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, THAILAND, TURKEY, UNITED ARAB EMIRATES, UNITED KINGDOM.", "openfda": { "k_number": [ "K210638", "K132482", "K123338", "K112226", "K093973", "K914866", "K160096", "K131475", "K242243", "K032590", "K151760", "K232955", "K991139", "K993418", "K211344", "K012985", "K203625", "K060747", "K120908", "K132952", "K053548", "K161452", "K140104", "K103305", "K103758", "K033836", "K063653", "K042231", "K251832", "K012145", "K972881", "K082461", "K030963", "K123560", "K960705", "K111451", "K150319", "K063254", "K032707", "K021914", "K033761", "K060625", "K180653", "K102672", "K151572", "K951314", "K153658", "K171862", "K082739", "K091641", "K050543", "K053160", "K090357", "K092666", "K014041", "K173614", "K132317", "K171747", "K103355", "K022420", "K100454", "K022427", "K951256", "K041649", "K093142", "K131948", "K032497", "K965174", "K200030", "K192068", "K031168", "K120686", "K030475", "K053197", "K071634", "K964021", "K260351", "K261772", "K262419", "K031852", "K021494", "K020434", "K162704", "K223386", "K090891", "K031578", "K173711", "K010026", "K161367", "K120274", "K143218", "K242154", "K963307", "K032542", "K071246", "K031049", "K160832", "K080379", "K033372", "K070656", "K072173", "K161429", "K001678", "K113412", "K093919", "K964367", "K071962", "K042297", "K032553", "K212455", "K083646", "K242582", "K073419", "K023089", "K962503", "K120330", "K901337", "K120850", "K052509", "K142429", "K162999", "K170852", "K141134", "K203432", "K151447", "K051560", "K062036", "K920324", "K142513", "K040694", "K030392", "K133310", "K900723", "K002056", "K032619", "K192955", "K252694", "K991549", "K925523", "K073442", "K925876", "K983483", "K113822", "K153594", "K944354", "K123377", "K254221", "K002181", "K220040", "K993415", "K233420", "K252700", "K993417", "K042539", "K112385", "K080666", "K022735", "K090168", "K911779", "K961923", "K913312", "K033813", "K001083", "K041551", "K080437", "K103008", "K094018", "K093358", "K113457", "K230284", "K913556", "K051425", "K070707", "K000651", "K032872", "K082324", "K080967", "K871047", "K891688", "K112181", "K050954", "K020033", "K090001", "K901721", "K222533", "K050700", "K172390" ], "registration_number": [ "", "3012543881", "2133641", "1043729", "3016245399", "3007628272", "3009380063", "3013353964", "3008837339", "9615728", "3013758550", "9614654", "3008307705", "3013944123", "3006950086", "9617601", "1820334", "3005168196", "3027595249", "3012536737", "3017961114", "3010173425", "3015550451", "1225687", "3044156918", "9616684", "3033589330", "2032364", "3031550970", "3010079067", "1226348", "3015531723", "3013556777", "3009761573", "3008114965", "3016591327", "3003524171", "2134265", "3012931345", "2126666", "2029214", "2124215", "3008881809", "3008824097", "3014162263", "2029275", "3016540856", "3043869342", "2030598", "3016609702", "3014644549", "1721676", "3010178296", "3008264254", "3015309643", "1220477", "2022435", "3008853977", "3007738736", "3007029079", "3002807295", "3015615738", "3015453963", "3000143502", "2011171" ], "fei_number": [ "", "3012543881", "1000306431", "3002095335", "1043729", "3002807036", "3007628272", "3009380063", "3013353964", "3008837339", "3016245399", "3002947440", "3013758550", "3008307705", "3013944123", "3006950086", "3005168196", "1820334", "3027595249", "3012536737", "3017961114", "3015550451", "3044156918", "3002808904", "3033589330", "3031550970", "1000518731", "3010079067", "3015531723", "1000220862", "3013556777", "3009761573", "3008114965", "3016591327", "3003524171", "3012931345", "2126666", "2124215", "3002808761", "3008881809", "3008824097", "3014162263", "3016540856", "3043869342", "3000203466", "3016609702", "3014644549", "1721676", "3008264254", "3015309643", "1220477", "2022435", "3008853977", "3003323921", "3003110073", "3007738736", "3007029079", "3002807295", "3015615738", "3001451463", "3015453963", "3002534070", "3000143502", "2011171", "3002913962" ], "device_name": "Device, Neurovascular Embolization", "medical_specialty_description": "Neurology", "regulation_number": "882.5950", "device_class": "2" } } ] }