{ "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": "203868", "product_res_number": "Z-0406-2024", "event_date_initiated": "2023-10-06", "event_date_posted": "2023-11-28", "recall_status": "Open, Classified", "res_event_number": "93301", "product_code": "NAY", "k_numbers": [ "K152448" ], "product_description": "Da Vinci Single-Site Wristed Needle Driver, REF: 478115, 5 mm", "code_info": "UDI:00886874113752/ Serial Numbers: T10220412, T10220420, T10220426, T10220503,\nT10220518, T10220629, T10220715, T10220721,\nT10220811, T10220819, T10220901, T10220909,\nT10220920, T10220923, T10220928, T10221101,\nT10221109, T10230207, T11221109", "firm_fei_number": "3001675293", "recalling_firm": "Intuitive Surgical, Inc.", "address_1": "1266 Kifer Rd Bldg 101 1266 Kifer Rd", "address_2": "Bldg 101", "city": "Sunnyvale", "state": "CA", "postal_code": "94086-5304", "additional_info_contact": "Ian Purdy\n408-523-2100", "reason_for_recall": "There is the potential for the needle drive to become dislodged and/or broken which could result in uncontrollable movement.", "root_cause_description": "Process control", "action": "On October 24, 2023, Intuitive issued a \"Urgent Medical Device Recall notification\" to all affected consignees via E.Mail. Intuitive asked consignees to take the following actions:\n\n1. Read and understand the contents of the letter.\n2. Locate and return all affected lots of 478115-03 in your inventory via the standard\nRMA process by calling Intuitive Customer Service based on your region below.\n3. Notify all surgeons, personnel, and sites using da Vinci X and da Vinci Xi Single Site\nWristed Needle Driver, PN 478115-03 that they should review and understand the\ncontents of this letter.\n4. Complete the attached Acknowledgement Form immediately and return it via\nemail to Intuitive as instructed on the form.\na. Please retain a copy of this letter and the acknowledgement form for\nyour files.\n5. Inform Intuitive of any Adverse Events* or quality problems concerning the use of\nthe subject device via the standard complaint process.\n6. For Customers in the US:\n7. Adverse reactions or quality problems experienced with the use of this product\nmay be reported to the FDA's MedWatch Adverse Event Reporting program either\nonline, by regular mail or by fax.\na. Complete and submit the report Online Regular Mail or Fax: Download\nform or call 1-800-332-1088 to request a reporting form, then complete\nand return to the address on the pre-addressed form or submit by fax to\n1-800-FDA-0178.\n8. Inform all affected personnel at your site who use da Vinci procedures when the\nreturn has been completed.", "product_quantity": "317 units", "distribution_pattern": "US: IL, FL, ID, SC, MI, TX, TN, NY, OR, CO, CA, MS, NJ, Puerto Rico\nOUS: South Korea", "openfda": { "k_number": [ "K182140", "K261824", "K192803", "K251227", "K081137", "K210918", "K173721", "K030578", "K243714", "K240502", "K182371", "K170713", "K130266", "K153276", "K191280", "K242427", "K123329", "K173585", "K181517", "K011281", "K093217", "K202571", "K220889", "K112584", "K170879", "K254192", "K180033", "K211784", "K241638", "K141075", "K173842", "K260695", "K090993", "K171426", "K043288", "K162973", "K143132", "K131962", "K240852", "K042855", "K200049", "K231224", "K171120", "K222827", "K162411", "K211325", "K060391", "K222839", "K101581", "K173415", "K232773", "K050369", "K152578", "K202166", "K050005", "K151794", "K182421", "K120215", "K143217", "K170644", "K192877", "K200473", "K171388", "K161271", "K170645", "K212054", "K022574", "K040948", "K232610", "K172643", "K063220", "K183086", "K161178", "K212101", "K170508", "K130726", "K250442", "K070947", "K252675", "K043153", "K243641", "K251739", "K183098", "K011002", "K220023", "K171947", "K223095", "K050802", "K230033", "K211595", "K214095", "K191482", "K110451", "K252350", "K251202", "K253986", "K072627", "K180351", "K152448", "K170865", "K170875", "K101743", "K250674", "K121921", "K171294", "K202968", "K080291", "K171632", "K112263", "K173906", "K251213", "K190999", "K211997", "K243582", "K242318", "K251817", "K233866", "K021152", "K192717", "K173337", "K191529", "K180163", "K202834", "K212747", "K150284", "K241284", "K123463", "K183224", "K990144", "K223080", "K241814", "K251324", "K231798", "K250786", "K021036", "K170641", "K171699", "K191736", "K002489", "K123840", "K141077", "K183107", "K251426", "K252069", "K113706", "K061260", "K040237", "K081207", "K140189", "K112208", "K140553", "K131861", "K213710", "K152421", "K150837", "K253556", "K012833", "K110639", "K152892", "K203632", "K240723", "K211316", "K122532", "K142683", "K082497" ], "registration_number": [ "", "3008309062", "3016096100", "3012453745", "3042953929", "3013868968", "3009719225", "3014644276", "3042940623", "3003537036", "3010860245", "3004784537", "3013283620", "3017619652", "3014656892", "3003898360", "3011063460", "3018126215", "3007487007", "2955842", "3014663814", "3033507886", "3009161688", "3015224777", "3010193531", "3010684280", "3011390076", "3015895145", "2032098", "3031594238", "3010432890", "3004111573", "3016079756", "3015612252", "3009941480", "8043903", "9611665", "3015153469", "3010157088", "3038187466", "3009217531", "1058584", "2246552", "3007593944", "1650907", "3015336263", "3011459762", "3012811961", "9681503", "9616517", "3013188547", "3001675293", "2032112", "3039523130", "3002259632", "3016832577", "3001592626", "3014635169", "3022626486", "8010877", "3013942591", "1061124", "3010493171", "2022435", "3014309390", "2029015", "2011171", "8010456", "1721686", "3017820152", "3017636737", "3026606306", "3038284218", "3015241782", "3007029079", "3007303113", "3010885402", "3010564249", "3017119401", "3008837339", "3013077751", "3013665681", "9614969", "3014579024", "3016555232", "2936485", "3018907196", "3012627460", "1531174", "1226146", "3005369776", "3016607092", "3038188839", "3007111496", "3012880598", "2029275", "3036035332", "3020331900" ], "fei_number": [ "", "3008309062", "3016096100", "3012453745", "3002807793", "3042953929", "3013868968", "3009719225", "3042940623", "3003537036", "3010860245", "3004784537", "3013283620", "3017619652", "3006149253", "3014656892", "3003898360", "3011063460", "3018126215", "1000160458", "3007487007", "3014663814", "3002993297", "3033507886", "3009161688", "1000306431", "3015224777", "3010193531", "3010684280", "3011390076", "3002477156", "3002807095", "3015895145", "1000219637", "3003076831", "3031594238", "3008615487", "3010432890", "3004111573", "3016079756", "3015612252", "3009941480", "1000512168", "3015153469", "3010157088", "3038187466", "3009217531", "2246552", "3007593944", "3015336263", "3011459762", "3012811961", "3013188547", "3001675293", "3039523130", "3002259632", "3016832577", "3001592626", "3014635169", "1000499348", "3022626486", "3013942591", "3010493171", "2022435", "3014309390", "2011171", "1721686", "3017820152", "3017636737", "3026606306", "3038284218", "3015241782", "3007029079", "3007303113", "3010885402", "3010564249", "3017119401", "3008837339", "3013077751", "3013665681", "3002681132", "3014579024", "3016555232", "3002808088", "2936485", "3018907196", "3012627460", "3005369776", "3016607092", "3002680121", "3942", "3038188839", "3007111496", "3012880598", "3003117688", "3036035332", "3003058448", "3020331900" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }