{ "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": "167388", "product_res_number": "Z-0249-2020", "event_date_initiated": "2018-06-04", "event_date_created": "2019-10-30", "recall_status": "Open, Classified", "res_event_number": "81073", "product_code": "NAY", "k_numbers": [ "K162973" ], "product_description": "EndoWrist Suction Irrigator, Single Use Instrument. Part Number: 480299-04. \nAn accessory to the EndoWrist Surgical System, used in endoscopic surgery.", "code_info": "Lots: T10180226 and onward; Part Numbers: 480299-04 (UDI 00886874114810)", "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": "800-876-1310", "reason_for_recall": "The firm has identified the potential for a silicone particle to be generated within the Suction Irrigator device. If generated, a particle may be introduced into the patient with irrigation.", "root_cause_description": "Process change control", "action": "On 06/04/2018, Medical Device Recall notices (Field Safety Notice Urgent Medical Device Correction- ISIFA2018-09-C) were emailed to U.S. consignees, and on 06/07/2018 notices were mailed via FedEx. Additionally on 06/08/2018 two (2) distributors received the notices via email and on 06/15/2018 two (2) EMEIA consignees received the notices by mail. The firm posted information regarding the voluntary field recall on their US Customer Portal on 06/04/2018. Customers were asked to:\n1. Stop-use of the affected products for intra-cardiac procedures until further notice from the Recalling Firm.\n2. Ensure surgeons and patient side assistants using the products have read and understand the content of the notification letter.\n3. Complete the attached Acknowledgement Form and return it via fax or email to U.S. FAX +1(408)523-0619, or Scan and Email Recalls@intusurg.com or for further questions contact Customer Service at:\n-North and South America: 800-876-1310 Option 3 (4 am to 5 pm PST)\n-Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET)\n4. Please retain a copy of the Customer Notification and the Acknowledgement form on file.", "product_quantity": "3108 units (518 boxes of 6 units)", "distribution_pattern": "Worldwide distribution. US nationwide, Australia, Italy, Switzerland, and United Kingdom.", "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" } } ] }