{ "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": 1 } }, "results": [ { "cfres_id": "217850", "product_res_number": "Z-1096-2026", "event_date_initiated": "2025-12-15", "event_date_posted": "2026-01-15", "recall_status": "Open, Classified", "res_event_number": "98187", "product_code": "NAY", "k_numbers": [ "K202571" ], "product_description": "da Vinci SP, SP Access Port Kit, Large Incision\n\nReference Numbers:430073 (2.7-4cm,SP1098, Box) & 430075 (2.7-7cm,SP1098,Box)", "code_info": "REF: 430073\nUDI: 00886874119549\nLot Numbers: U80240110\tK10250114\tK10250305\tK10250306\tK10250313\tK10250414\tK10250424\tK10250514\tK10250522\tK10250619\tK10250626\tK10250629\tK10250630\tK10250710\tK10250716\tK10250717\tK10250731\tK10250804\tK10250806\tK10250828\tK10250904\tK11250113\tK11250807\tK11250821\tK11250828\tK11250911\tK12250821\tU10241101\tU10241115\tU10250108\tU10250207\tU10250210\tU10250307\tU10250310\tU10250313\tU10250321\tU10250325\tU10250331\tU10250414\tU10250425\tU10250506\tU10250509\tU10250521\tU10250528\tU10250604\tU11241101\tU11241121\tU11241210\tU11250123\tU11250219\tU11250404\tU11250425\tU11250521\tU12250219\tU80231207\tU80231219\tU80240118\tU80240125\tU80240201\tU80240222\tU80240306\tU80240319\tU80240402\tU80240411\tU80240417\tU80240523\tU80240617\tU80240620\tU80240806\tU80240812\tU80240905\tU80240911\tU80241017\tU80241025\tU81231219\tU81240118\tU81240125\tU81240306\tU81240319\tU81240402\tU81240411\tU81240417\tU81240617\tU81240620\tU81240627\tU81240806\tU81240905\tU81240911\tU82231219\n\n\nREF: 430075\nUDI: 00886874119556\nLot Numbers: U81240125\tU80240201\tU80240222\tU80240125\tU81240215\tU81240208\tU80240208\tU81240201\tU81240229\tU80240326\tU80240529\tU80240229\tU81240222\tU80240711\tU81240606\tU80240606\tU80240812\tU80240731\tU80240917\tU10241107\tU80241003\tU10241217\tU10250123\tU10250305\tU10250219\tU10250102\tK10250313\tU10250414\tU10250423\tK10250529\tK10250522\tU10250529\tK10250701\tK10250702\tK10250717\tK11250814\tK10250807\tK11250813\tK10250605\tU80240611\tK10250327\tU80240425\tU10250312\tK10250515\tK11250515\tU10250318\tU80240724\tU10250115\tU10250326\tU80240130\tU80240627\tK10250113\tK11250529\tK10250723\tU80240717\tU80240215\tU10250501\tK10250403\tU10250515\tK12250904", "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": "Access Port System tray may develop cracks potentially resulting in a sterility breach.", "root_cause_description": "Packaging change control", "action": "On December 15, 2025, Intuitive Surgical Inc. issued a Urgent: Medical Device Recall Notification via mail and email. Intuitive asked consignees to take the following actions: \n\n1.\tFollow the warning provided in the SP Access Port Kit User Manual Addendum \n2.\tIdentify Affected Product: Please inspect the product label to confirm the Part Number and Lot Number.\n3.\tIf the product label indicates a Lot Number within the affected range specified, proceed with the following actions 4 and 5 below. \n4.\tQuarantine affected inventory: Immediately segregate and quarantine all affected units to prevent clinical use.\n5.\tReturn affected product. \n6.\tForward this notice to all individuals within your organization who need to be aware.\n7.\tComplete the attached Acknowledgement Form immediately and return it to Intuitive via fax or email as instructed on the form.\n8.\tPlease retain a copy of this letter, place a copy with your affected system, and keep the acknowledgement form for your files.\n9.\tPlease inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems.\n10.\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.", "product_quantity": "41,526 units", "distribution_pattern": "Worldwide - US Nationwide distribution including in the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nevada, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin and the countries of Australia, Austria, Belgium, China, Czech Republic, Denmark, France, Germany, Greece, Hong Kong, Ireland, Italy, Japan, Poland, Romania, Saudi Arabia, South Korea, Spain, Sweden, Switzerland, Taiwan, United Arab Emirates, United Kingdom.", "openfda": { "k_number": [ 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"3009941480", "3042953929", "3044545674", "3002807095", "3011063460", "3010564249", "3036035332", "1000306431", "3022626486", "3018126215", "3002993297", "3012453745", "3008837339", "3003898360", "3002477156", "3010684280", "3016555232", "3002808088", "3015336263", "3009719225", "3013942591", "3018907196", "3002681132", "3003117688", "3016832577", "3009217531", "3010432890", "3038187466", "3008309062", "3016096100", "3017820152", "2936485", "3012627460", "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" } } ] }