{ "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": "218632", "product_res_number": "Z-1700-2026", "event_date_initiated": "2025-12-09", "event_date_posted": "2026-03-30", "recall_status": "Open, Classified", "res_event_number": "98408", "product_code": "NAY", "k_numbers": [ "K050369" ], "product_description": "Brand Name: da Vinci S, Si Tenaculum Forceps Instrument\nProduct Name: da Vinci S, Si Tenaculum Forceps Instrument\nModel/Catalog Number: 420207\nSoftware Version: N/A\nProduct Description: EndoWrist Instruments or Da Vinci S/Si Reusable instruments, including blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories are intended for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories. Please refer to attached User Manual for additional details on intended use.\n\nAll da Vinci S/Si reusable instruments with jaws use mechanical tungsten cables and pulleys to transmit motion from the input discs to the housing (on the proximal chassis), through the main shaft, and the distal instrument tip (inside the patient).\nComponent: N/A", "code_info": "Lot Code: 420207: Tenaculum Forceps Instrument\nGTIN: 00886874111659\nFDA Medical Device Number: D088920\n\nMaterial Number: 420207-06\nda Vinci System Numbers:\nSH1378\nSH0935\nSH0935\nSH0935\nUSG294\nSH0761\nSH0729\nSH1182\nSH1378\nUSG022\nSH1378\nSH1368\nSH0059\nSH1015\nSH1182\nSH0825\nUSG294\nSH1390\nUSG022\nSH0495\nSH0495\nSH1076\nSH1390\nSH1390\nSH1390\nSH1276\nSH1385\nUSG022\nSH0547\nSH1385\nSH1391\nSH2144\nSH0059\nSH1279\nSH0059\nSH1390\nSH1570\nSH0059\nSH1391\nSG704\nSH1570\nSH0729\nSH1385\nSH1378\nUSG518\nSH1385\nSH1837\nUSG294\nSH1368\nSH1390\nSH1385\nSH1368\nSG2026\nSH1557\nSH2144\nSH1385\nUSG518\nSH1279\nUSG294\nSH1391\n\nMaterial Number: 420207-07\nda Vinci System Numbers:\nSH1391\nSH1385\nSH1385\nSH1279\nSH2125\nSH0729\nSH1368\nUSG721\nSH1385\nSH1997\nSH2125\nUSG294\nSH1378\nSH1997\nSH0035\nSG704\nSH1385\nSH1279\nSH1279\nSH2125\nSH1378\nSH1378\nSH0495\nSH1390\nSH1390\nSH1385\nSH2125\nSH1378\nSH1385\nSH1279\nUSG721\nSH1279\nSH1837\nUSG518\nSH1385\nSH1378\nUSG022\nSH1378\nSH1570\nSH1385\nSH1385\nSH0935\nSH0935\nSG704\nSG704\nSH1378\nUSG022\nSH1385\nSH1279\nUSG721\nSH1279\nUSG518\nSH1837\nSH1279\nUSG022\nSH1385\nSH1385\nSH1964\nSH1385\nSH1390\nSH1279\nSH1964\nSH1385\nSH1570\nUSG294\nSH1182\nSH1279\nSH1279\nUSG022\nSH1385\nSH0825\nUSG294\nSH0035\nSH1276\nSH2125\nSH1279\nRSH0152\nUSG518\nSH1557\nSH1837\nSH1385\nSH1390\nSH1279\nSH1390\nSH1390\nUSG294\nSH1385\nSH1279\nSH1385\nSH1279\nSH2125\nUSG721\nSH1837\nSH0035\nSH1964\nSH1837\nSH1385\nSH1385\nSH1279\nSH1279\nRSH0152\nSH1378\nSH0495\n\nMaterial Number: 420207-09\nda Vinci System Numbers:\nRSH0152\nSH1378\nSH1385\nSH1279\nUSG721\nSH1279\nSH1378\nSH1385\nUSG721\nSH1279\nSH1182\nSH1390\nSH1076\nUSG721\nSH1279\nSH1182\nSH1385\nSH1837\nSH1279\nSH1837\nSH1279\n\nMaterial Number: 420207-10\nda Vinci System Numbers:\nSH1279\nSH1385\nSH1390\nSH1279\nSH1385\nSH1182\nSH1368\nSH1997\nSH1279\nUSG721\nSH1822\nSH1557\nSH1822\nSH1964\nSH1279\nSH0495\nSH1390\nSH1279\nSH1964\nUSG022\nSH1822\nSH1378\nSH1182\nSH1837\nSH1279\nSH1279\nSH1279\nSH1279\nSH1997\nSH1964\nSH1964\nSH1997\nSH0761\nSH1279\nSH1837\nSH1279\nSH1279\nSH1279\nSH1390\nSH1279\nSH1997", "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 increased in complaints regarding frayed or broken pitch cables on reusable surgical instruments", "root_cause_description": "Process change control", "action": "On 12/29/2025, the firm email and sent via overnight priority mail an \"Urgent: Medical Device Recall\" letter to customers informing them of possible pitch cable failures on the da Vinci S and Si Tenaculum Forceps and Permanent Cautery Hooks reusable instruments.\n\nCustomers are instructed to:\n1. Complete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form.\n2. Please identify and quarantine any affected product(s). Affected product(s) listed above may be returned by sending an email with quantities and lot numbers to your regional customer service.\n3. Please ensure to include the FSCA number ISIFA2025-16-R in your return notes.\n4. Credit will be provided based on the number of remaining lives.\n5. If affected products were shared or further distributed with other sites, make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.\n6. Please retain a copy of this letter and the acknowledgement form for your files.\n7. Inform Intuitive of any Adverse Events*/Serious Incidents** or quality problems concerning the use of the subject devices via the standard complaint process.\n\nFor further information or support, contact Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below:\n\" North and South America: (800) 876-1310, Option 3 (4 am to 5 pm PST) or mail: customerservice@intusurg.com.\n\" Europe, Middle East, Asia and Africa: +800 0821 2020 or +41 21 821 2020 (8 am to 6 pm CET) or eucs@intusurg.com\n\" South Korea: 02-3271-3200 (9 am to 6 pm KSTJ) or support.korea@intusurg.com\n\" Japan: 0120-56-5635 or 03-5575-1362 (9 am to 6 pm JST) or csjapan@intusurg.com\n\" India: +1-800-103-6952 (9 am to 6 pm IT)\n\" Taiwan: +0800-86-8181 (9 am to 6 pm CT)", "product_quantity": "2095 instruments", "distribution_pattern": "U.S. Nationwide distribution in the states of AR, CA, CT, FL, IA, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NJ, NM, NY, NC, OH, PA, TX, VA, and WA. The countries of Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guadeloupe, Hong Kong, India, Indonesia, Italy, Japan, Kuwait, Lebanon, Malaysia, Mexico, Pakistan, Philippines, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, South Africa, South Korea, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and 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", "K002489", "K070947", "K170875", "K182421", "K220889", 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"K212054", "K251227", "K143217", "K210918", "K202571", "K200049", "K080291", "K110639", "K222827", "K191736", "K170865", "K240502", "K231798", "K251213", "K220023", "K241284", "K173415", "K242427", "K171294", "K173906", "K040948", "K171947", "K170713", "K170508", "K211325", "K171120", "K242318", "K172643", "K213710" ], "registration_number": [ "2955842", "3011459762", "3015612252", "3031594238", "3002259632", "3017619652", "3017119401", "3007303113", "3015224777", "3010157088", "3014309390", "8043980", "2246552", "3004111573", "3007111496", "3014656892", "3015153469", "3010493171", "3001556604", "9611665", "3010860245", "3014635169", "3013868968", "3013665681", "3009161688", "2029015", "1226146", "1531174", "3013077751", "3048246462", "9616517", "3042940623", "2029275", "3012811961", "3003537036", "3001592626", "3014663814", "3017636737", "3015241782", "1058584", "3014579024", "3001675293", "3033043422", "3026606306", "2011171", "3004784537", "3007029079", "3015895145", "3005369776", 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"1721686", "3013283620" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }