{ "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": "2026-10-22", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "212603", "product_res_number": "Z-1325-2025", "event_date_initiated": "2025-02-26", "event_date_posted": "2025-03-12", "recall_status": "Open, Classified", "res_event_number": "96345", "product_code": "NAY", "k_numbers": [ "K232610" ], "product_description": "Brand Name: Da Vinci 5\nProduct Name: ASSY,DV5 CONSOLE,IS5000 Foot Tray Pedals\nModel/Catalog Number: 380730\nSoftware Version: N/A\n. \n\nRefer to HHE for additional details.\nComponent: N/A", "code_info": "UDI: 00886874119747/ All da Vinci dV5 consoles and foot trays assemblies manufactured prior to 12/20/2024.", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Shahbaz Khan\n1-408-5232443", "reason_for_recall": "Due to an increase in complaints concerning foot tray pedal spring failing resulting in the pedal remaining pressed", "root_cause_description": "Device Design", "action": "On February 26, 2025, Intuitive Surgical issued a Urgent: Medical Device Correction to affected consignees via E-Mail. Intuitive asked consignees to take the following actions: \n\n\n1.\tRead and understand this notification.\n2.\tShare this notification with all personnel at your site who perform and support da Vinci procedures.\n3.\tInform affected personnel when the correction has been completed.\n4.\tComplete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. \n5.\tPlease retain a copy of this letter and the acknowledgement form for your files.\n6.\tPlease inform Intuitive of any Adverse Events* or quality problems concerning the use of the subject devices via the standard complaint process\n7.\tAdverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. \n8.\tComplete and submit the report Online Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178. An Intuitive representative will schedule a visit to replace the affected foot tray assembly.", "product_quantity": "439 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Alaska, Arizona, Arkansas, California, Colorado, Connecticut, District of Columbia, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Jersey, New Mexico, New York, North Carolina, North Dakota, Ohio, Oklahoma, Oregon, Pennsylvania, \tSouth Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, \tWisconsin, Wyoming and the country of South Korea.", "openfda": { "k_number": [ "K242427", "K002489", "K143132", "K043288", "K072627", "K070947", "K250442", "K123840", "K232610", "K093217", "K153276", "K202166", "K211595", "K253556", "K242318", "K040237", "K241638", "K183107", "K202968", "K121921", "K161271", "K061260", "K251227", "K110451", "K171120", "K171699", "K202834", "K261824", "K063220", "K251213", "K230033", "K200473", "K183098", "K182140", "K183224", "K040948", "K260695", "K112263", "K173906", "K231798", "K130726", "K231224", "K131861", "K214095", "K252350", "K081207", "K183086", "K171632", "K060391", "K253986", "K030578", "K170865", "K171426", "K050005", "K170879", "K211997", "K042855", "K182371", "K192877", "K021152", "K143217", "K050802", "K140189", "K141077", "K011281", "K172643", "K241814", "K110639", "K212101", "K990144", "K203632", "K170508", "K211784", "K250674", "K173585", "K251202", "K240852", "K181517", "K261823", "K211316", "K192803", "K170713", "K101743", "K021036", "K251324", "K254192", "K241284", "K202571", "K220023", "K180351", "K233866", "K212747", "K222827", "K252069", "K170645", "K171947", "K012833", "K243582", "K191280", "K220889", "K050369", "K191736", "K130266", "K151794", "K240502", "K171294", "K173337", "K173721", "K252675", "K043153", "K152578", "K150284", "K022574", "K173415", "K162973", "K182421", "K090993", "K222839", "K250786", "K211325", "K243641", "K150837", "K232773", "K161178", "K170641", "K112584", "K223095", "K212054", "K170644", "K180033", "K123463", "K171388", "K192717", "K190999", "K081137", "K120215", "K162411", "K152421", "K082497", "K140553", "K152892", "K180163", "K170875", "K213710", "K080291", "K243714", "K240723", "K251739", "K210918", "K142683", "K141075", "K200049", "K122532", "K223080", "K251817", "K101581", "K152448", "K123329", "K131962", "K191482", "K191529", "K251426", "K113706", "K112208", "K173842", "K011002" ], "registration_number": [ "", "9614969", "9611665", "3018907196", "2246552", "3015224777", "1650907", "3013868968", "1531174", "3010885402", "3016555232", "2955842", "3017619652", "3003898360", "3013188547", "3001556604", "3036035332", "3014663814", "3038188839", "3012453745", "1058584", "3004111573", "3026606306", "3015895145", "3020331900", "3007487007", "3014644276", "3015153469", "3010860245", "3005369776", "3015241782", "3010157088", "3001675293", "2022435", "3011390076", "2032098", "3012811961", "3010564249", "3014579024", "3017820152", "3014635169", "3009161688", "3009941480", "3007303113", "8043980", "3008837339", "3003537036", "3010684280", "2011171", "3017119401", "3016832577", "3007111496", "1721686", "1061124", "2032112", "3022626486", "3033507886", "3013283620", "8010877", "3015612252", "8043903", "3014309390", "3013942591", "3013665681", "2936485", "3007029079", "3012627460", "8010456", "3044545674", "2029015", "9616517", "3001592626", "1226146", "2029275", "3033043422", "3010493171", "3031594238", "3004784537", "3010432890", "3013077751", "3014656892", "3016607092", "3009719225", "3009217531", "3011459762", "3011063460", "3035387162", "3038187466", "3016096100", "3042940623", "3018126215", "3042953929", "3017636737", "3008309062", "9681503", "3002259632", "3010193531", "3015336263", "3016079756" ], "fei_number": [ "", "3002680121", "3002914049", "3018907196", "2246552", "3015224777", "3013868968", "3010885402", "3016555232", "3003058448", "3017619652", "3003898360", "3013188547", "3001556604", "3002681132", "3036035332", "3014663814", "3038188839", "3012453745", "3004111573", "3026606306", "1000512168", "3015895145", "3020331900", "3007487007", "1000306431", "3015153469", "3010860245", "3005369776", "3015241782", "3010157088", "3001675293", "2022435", "3011390076", "3003076831", "3012811961", "3010564249", "3014579024", "3017820152", "3014635169", "3009161688", "3009941480", "3007303113", "3008837339", "3003537036", "3010684280", "2011171", "3002807793", "3002993297", "3017119401", "3942", "3016832577", "3007111496", "1721686", "3022626486", "3033507886", "3013283620", "3002807095", "1000219637", "3015612252", "3014309390", "3013942591", "3006149253", "3002808088", "3013665681", "2936485", "3007029079", "3012627460", "3044545674", "3001592626", "3033043422", "3002477156", "3010493171", "3008615487", "3031594238", "1000160458", "3004784537", "3010432890", "3013077751", "3014656892", "3016607092", "3009719225", "3009217531", "3011459762", "3003117688", "3011063460", "3035387162", "3038187466", "3016096100", "3042940623", "3018126215", "3042953929", "3017636737", "3008309062", "3002259632", "1000499348", "3010193531", "3015336263", "3016079756" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }