{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "53388", "product_res_number": "Z-0258-2008", "event_date_initiated": "2007-04-13", "event_date_posted": "2008-01-24", "recall_status": "Terminated", "event_date_terminated": "2008-08-01", "res_event_number": "38312", "product_code": "NAY", "k_numbers": [ "K061260" ], "product_description": "Intuitive Surgical EndoWrist, 8 mm, PK Dissecting Forceps for use with the da Vinci and da Vinci S Surgical systems, Part Numbers: 400214-02, 400214-03, 420214-02 and 420214-03, Intuitive Surgical, Inc., Sunnyvale, CA", "code_info": "All instruments manufactured till 03/21/07", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "950 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5206", "additional_info_contact": "408-523-2100", "reason_for_recall": "Mislabeling-electrical isolation requirements: devices were incorrectly labeled with a CF symbol not their proper BF Symbol on the instrument housing. (All instruments meeting the CF isolation requirements are suitable for direct cardiac application, while instruments meeting BF isolation requirements are not suitable for direct cardiac application)", "root_cause_description": "Device Design", "action": "On January 9, 2008, via an Urgent Device Recall Letter the recalling firm notifed users of the defect (mislabeling with heart symbol) and to Immediately Discontinue any direct cardiac applications. The recalling firm will arrange with each consignee a time to relabel their devices. Customers on April 17, 2007 had earlier been warned of the device defect via letter but no correction was indicated.", "product_quantity": "1,136 units", "distribution_pattern": "Worldwide Distribution --- USA including states of MN, PA, AK, NY, CA, MD, IN, AZ, CO, AR, TX, TN, FL, VA, MA, NE, NC, IL, OH, ME, WI, MD, NJ, MN, MI, VA, IA, OR, MO, NC, MS, AL, WA, GA, KY, LA, AK, AR, SD, SC, DE, NV, HI, NH, WV, and CT, and countries of Canada, Australia, Belgium, Spain, Hong Kong, Italy, Switzerland, and Sweden. ( 192 USA hospitals, 3 foreign hospitals and 5 foreign distributors)", "openfda": { "k_number": [ "K152892", "K252350", "K122532", "K211997", "K254192", "K120215", "K171120", "K171947", "K223080", "K251817", "K140189", "K233866", "K123840", "K170875", "K253986", "K242318", "K240502", "K042855", "K170713", "K191280", "K123329", "K230033", "K093217", "K121921", "K173842", "K990144", "K131962", "K210918", "K231798", "K211595", "K182140", "K241814", "K214095", "K002489", "K253556", "K171632", "K161271", "K170508", "K080291", "K220889", "K240723", "K170641", "K182371", "K181517", "K242427", "K232610", "K251227", "K151794", "K153276", "K211325", "K171388", "K170644", "K170879", "K241638", "K072627", "K040948", "K251426", "K213710", "K192803", "K022574", "K180163", "K101743", "K243714", "K192717", "K011002", "K012833", "K021036", "K101581", "K250674", "K212054", "K113706", "K171699", "K150837", "K243641", "K240852", "K172643", "K131861", "K202968", "K252069", "K192877", "K231224", "K212747", "K040237", "K021152", "K081207", "K143217", "K191482", "K170865", "K243582", "K200473", "K173415", "K173721", "K182421", "K222839", "K180351", "K183107", "K260695", "K112584", "K030578", "K203632", "K251739", "K223095", "K110639", "K043153", "K232773", "K171294", "K050005", "K202834", "K063220", "K110451", "K123463", "K180033", "K252675", "K152421", "K162411", "K060391", "K190999", "K250786", "K261824", "K191529", "K050369", "K082497", "K250442", "K170645", "K162973", "K202166", "K141077", "K112208", "K241284", "K141075", "K251202", "K173585", "K161178", "K081137", "K183086", "K061260", "K112263", "K143132", "K140553", "K173906", "K211316", "K222827", "K152448", "K251213", "K152578", "K142683", "K212101", "K050802", "K090993", "K171426", "K183224", "K130726", "K011281", "K211784", "K220023", "K173337", "K183098", "K070947", "K191736", "K150284", "K251324", "K130266", "K043288", "K202571", "K200049" ], "registration_number": [ "3003898360", "", "8043903", "9681503", "3011459762", "3038284218", "3013188547", "3014656892", "3009941480", "2032112", "3010684280", "3015895145", "3011063460", "3007487007", "3010157088", "2936485", "3018907196", "3036035332", "1531174", "2029015", "3022626486", "3014644276", "3012627460", "3016555232", "3009719225", "3016832577", "3014663814", "8010877", "3010193531", "3014635169", "3013077751", "3004111573", "3012880598", "2032098", "1650907", "2011171", "1061124", "3016607092", "3015336263", "3008837339", "9614969", "3018126215", "3042953929", "3010564249", "1721686", "3005369776", "2022435", "3013942591", "2955842", "3020331900", "3009161688", "3017636737", "3009217531", "3011390076", "1058584", "3017820152", "3001675293", "8010456", "3017119401", "3014309390", "3012811961", "3013283620", "3010432890", "3015153469", "3003537036", "3014579024", "3001592626", "3026606306", "3010885402", "3010860245", "3015224777", "3038188839", "3015612252", "3004784537", "9616517", "2246552", "3007303113", "3008309062", "3039523130", "3038187466", "3033507886", "3007111496", "3017619652", "2029275", "3016096100", "3016079756", "3042940623", "3012453745", "3013868968", "3010493171", "3002259632", "1226146", "3013665681", "9611665", "3031594238", "3007593944", "3015241782", "3007029079" ], "fei_number": [ "3003898360", "", "1000219637", "3003076831", "1000160458", "3011459762", "3038284218", "3003117688", "3013188547", "3014656892", "3009941480", "3010684280", "3015895145", "1000306431", "3011063460", "3007487007", "3010157088", "2936485", "3018907196", "3036035332", "3022626486", "3002477156", "3012627460", "3002807095", "3016555232", "3009719225", "3016832577", "3014663814", "3010193531", "3002808088", "3014635169", "3013077751", "3004111573", "3012880598", "3002993297", "2011171", "3016607092", "3015336263", "3008837339", "3018126215", "3042953929", "3010564249", "3002807793", "1721686", "3005369776", "2022435", "3013942591", "3020331900", "3009161688", "3006149253", "3017636737", "3009217531", "3011390076", "3017820152", "3001675293", "3017119401", "3014309390", "3012811961", "3013283620", "3010432890", "3015153469", "3002681132", "3003537036", "3014579024", "3001592626", "3026606306", "3010885402", "3010860245", "3015224777", "3008615487", "3038188839", "3015612252", "3004784537", "1000512168", "2246552", "3007303113", "3008309062", "3039523130", "3038187466", "3033507886", "3007111496", "3017619652", "3003058448", "3016096100", "3016079756", "3042940623", "3012453745", "3013868968", "3010493171", "3942", "3002259632", "3013665681", "3002680121", "1000499348", "3031594238", "3007593944", "3015241782", "3007029079" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }