{ "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": "131215", "product_res_number": "Z-0430-2015", "event_date_initiated": "2014-11-03", "event_date_posted": "2014-11-25", "recall_status": "Terminated", "event_date_terminated": "2015-02-03", "res_event_number": "69638", "product_code": "NAY", "k_numbers": [ "K131861" ], "product_description": "8MM,LONG TIP FORCEPS;\n\nIntended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments.", "code_info": "Part number:470093-04; All 8mm da Vinci Xi (IS4000) Surgical System instruments manufactured with white colored housings.", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 100 1266 Kifer Rd", "address_2": "Bldg 100", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Mark Johnson\n408-523-2100", "reason_for_recall": "Deviations in reprocessing steps from those stated in the reprocessing instructions can cause surface degradation of the housing and/or accelerate mechanical wear of the instrument.", "root_cause_description": "Labeling design", "action": "Urgent Medical Device Recall letters were sent to affected sites on November 3, 2014. Letters inform customers of the reason for recall, risk to health and the affected instrument. A table of all of the affected IS4000 instruments affected is attached to the letter indicating the part number and product name for each. Letters also inform customers that all instruments shipped since July 2014 are manufactured with a new material and not subject to recall.\nCustomers are to take the following actions:\n1. Ensure that all affected personnel are aware of the information.\n2. Identify affected product in their possession\n3. Contact ISI rep for replacement.\n4. Complete and return the attached Acknowledgement From.\nUntil replacement instruments are received, the old instruments may be used provided they do not show signs of degradation and that the reprocessing instructions are followed. Questions to 800-876-1310 Option 3 ( 6 am to 5 pm PST) or ics@intusurg.com.", "product_quantity": "509 units - total all affected devices", "distribution_pattern": "US Distribution -- FL, TX, NY, NV, OR, IN, UT, and MA.", "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" } } ] }