{ "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": "2026-09-10", "results": { "skip": 0, "limit": 1, "total": 2 } }, "results": [ { "cfres_id": "192095", "product_res_number": "Z-1209-2022", "event_date_initiated": "2022-03-03", "event_date_created": "2022-05-31", "recall_status": "Open, Classified", "res_event_number": "89641", "product_code": "NAY", "k_numbers": [ "K173337" ], "product_description": "VESSEL SEALER EXTEND, Single-Use Instrument EndoWrist Instruments 8mm, da Vinci X' da Vinci Xi', REF 480422", "code_info": "UDI: 00886874115664. All lots", "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": "Customer Service\n800-876-1310 Ext. 3", "reason_for_recall": "Placing excessive tissue in the instrument jaws of the devices prior to sealing and transection can result in an insufficient seal.", "root_cause_description": "Use error", "action": "On 03/03/22, a Field Safety Notice was sent via courier service to customers.\n\nIn section 4, \"Actions to be taken by the Customer/User\" of the Field Safety Notice includes the following:\n\nPlace the customer communication with the User Manual. In addition,\n1.\tRead and understand the contents of the letter. \n2.\tNotify all surgeons and personnel using the System that they should reacquaint themselves by\na.\tReading the instructions, warnings, and cautions provided in the Instruments and Accessories User Manual Addendum /User Manual \nb.\tContacting Sales Representatives for clarification of queries.\n3.\tComplete the Acknowledgement Form immediately and return it via fax or email as instructed on the form. \n4.\tRetain a copy of the letter and the acknowledgement form for your files.\n5.\tInform of any adverse events/serious incidents or quality problems concerning the use of the subject devices via the standard complaint process. \n6.\tAdditionally, if adverse events/serious incidents or quality problems are experienced, follow the standard reporting process to the health authority, if applicable.\nThe use of the instruments may be continued by following instructions provided in Section 1 of the notice and warnings and cautions listed in the user manuals.\n\nThere will be follow up with updated user documentation once available.\n\nIf further information is needed or support concerning the Medical Device Correction, contact the Clinical Sales Representative or contact Customer Service at the numbers listed below: \n\"\tUS, Puerto Rico and Dominican Republic (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com\n\"\tEurope, Middle East, Asia, South America and Africa: +800 0821 2020 or +41 21 821 2020 (8 AM to 6 PM CET) or EUCS@intusurg.com \n\"\tSouth Korea: 02-3271-3200 (9 AM to 6 PM KSTJ) or support.korea@intusurg.com \n\"\tJapan: 0120-56-5635 or 03-5575-1362 (9 AM to 6 PM JST) or csjapan@intusurg.com\n\"\tTaiwan: 886-2-27008181 (7:30am to 5:30pm CT) or CS.Ta", "product_quantity": "140,519 boxes (843,113 individual units)", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries/regions of Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, Colombia, Cyprus, Czech Republic, Denmark, Ecuador, Finland, France, Germany, Greece, Guadeloupe, Hong Kong, Hungary, India, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Malaysia, Malta, Martinique, Mexico, Monaco, Netherlands, New Zealand, Norway, Panama, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Saudi Arabia, Singapore, Slovakia, Slovenia, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Venezuela, Vietnam.", "openfda": { "k_number": [ "K251324", "K183107", "K170879", "K183098", "K191280", "K011281", "K112263", "K131861", "K211316", "K173721", "K123463", "K240723", "K012833", "K152892", "K153276", "K200473", "K130266", "K150284", "K192877", "K182371", "K212747", "K250786", "K203632", "K021036", "K043153", "K161271", "K042855", "K233866", "K050005", "K162973", "K143132", "K254192", "K180163", "K202834", "K141077", "K061260", "K173585", "K173337", "K214095", "K123840", 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"3038188839", "3033507886", "3007487007", "3011390076", "1721686", "3013283620" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }