{ "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": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "196688", "product_res_number": "Z-0340-2023", "event_date_initiated": "2022-10-07", "event_date_posted": "2022-11-30", "recall_status": "Open, Classified", "res_event_number": "91080", "product_code": "NAY", "k_numbers": [ "K211997" ], "product_description": "INTUITIVE Da Vinci Xi 8mm SureForm 30 Curved-Tip Stapler Da Vinci Xi|X REF 488530\n\nINTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Gray 4-Row 2.0 mm Xi|X REF 48230M\n\nINTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm White 4-Row 2.5 mm Xi|X REF 48230W\n\nINTUITIVE Da Vinci 8mm SureForm 30 Reload 30 mm Blue 4-Row 3.5 mm Xi|X REF 48230B", "code_info": "Model Name / Model Number / UDI-DI Code:\nDa Vinci Xi 8mm SureForm 30 instruments\n488530-10\n10886874121723\n\nDa Vinci Xi 8mm SureForm 30 Grey Reload\n48230M-02\n10886874121938\n\nDa Vinci Xi 8mm SureForm 30 White Reload\n48230W-02\n10886874121921\n\nDa Vinci Xi 8mm SureForm 30 Blue Reload\n48230B-02\n10886874121914\n\nAll Serial Numbers", "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": "Alex Mathews\n408-523-2100", "reason_for_recall": "Potential staple deployment failure and device fragment generation", "root_cause_description": "Nonconforming Material/Component", "action": "On 10/07/2022, Intuitive Surgical communicated an \"Urgent Product Safety Notice\" email to \"STOP USE of da Vinci Xi 8mm SureForm 30 Stapler Instruments (488530-10) and Reloads (48230M-02, 48230W-02, 48230B-02)\" and informing customers that there is a potential to transect targeted tissue without stapler formation that could result in bleeding and potential to generate fragments when using these products.\n\nOn or about 10/25/2022, the firm sent an \"Urgent Medical Device Removal\" Letter via FedEx that informed their customers of the STOP USE.\n\nCustomers are instructed to:\nLocate and return all affected products, as listed above, in their inventory via the standard RMA process by calling Intuitive Customer Service at (800) 876-1310, Option 3, 4 AM to 5 PM PST. If they have shared these products with other sites, make sure appropriate staff at that site receive and understanding this notification so that they locate and return their affected product.\n\nCustomers may continue to use the da Vinci 12mm SureForm 45/60 instruments and reloads, as well as EndoWrist Stapler instruments and reloads, as these instruments are not impacted by this issue and use a different technology to effect stapler formation.\n\nFor questions or further information:\nContact their Clinical Sales Representative or contact Intuitive Customer Service at the numbers listed below:\n- US, Puerto Rico and Dominican Republic: (800) 876-1310, Option 3 (4 AM to 5 PM PST) or mail: customerservice@intusurg.com", "product_quantity": "160 boxes of 488530-10 = 960 individual instruments 602 reload boxes = 7224 individual reloads", "distribution_pattern": "U.S.: Arizona, California, Colorado, Florida, Illinois, Indiana, Louisiana, Maryland, Massachusetts, Michigan, Minnesota, Nevada, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia, Washington, and Wisconsin.\n\nO.U.S.: None", "openfda": { "k_number": [ "K152892", "K252350", "K122532", "K211997", "K254192", "K120215", "K171120", "K171947", "K223080", "K251817", "K140189", "K233866", "K123840", "K170875", "K253986", "K242318", "K240502", "K042855", "K170713", "K191280", "K123329", "K230033", "K093217", "K121921", "K173842", "K990144", "K131962", "K210918", "K231798", "K211595", "K182140", "K241814", "K214095", "K002489", "K253556", "K171632", "K161271", "K170508", "K080291", "K220889", "K240723", "K170641", "K182371", "K181517", "K242427", "K232610", "K251227", "K151794", "K153276", "K211325", "K171388", "K170644", "K170879", "K241638", "K072627", "K040948", "K251426", "K213710", "K192803", "K022574", "K180163", "K101743", "K243714", "K192717", "K011002", "K012833", "K021036", "K101581", "K250674", "K212054", "K113706", "K171699", "K150837", "K243641", "K240852", "K172643", "K131861", "K202968", "K252069", "K192877", "K231224", "K212747", "K040237", "K021152", "K081207", "K143217", "K191482", "K170865", "K243582", "K200473", "K173415", "K173721", "K182421", "K222839", "K180351", "K183107", "K260695", "K112584", "K030578", "K203632", "K251739", "K223095", "K110639", "K043153", "K232773", "K171294", "K050005", "K202834", "K063220", "K110451", "K123463", "K180033", "K252675", "K152421", "K162411", "K060391", "K190999", "K250786", "K261824", "K191529", "K050369", "K082497", "K250442", "K170645", "K162973", "K202166", "K141077", "K112208", "K241284", "K141075", "K251202", "K173585", "K161178", "K081137", "K183086", "K061260", "K112263", "K143132", "K140553", "K173906", "K211316", "K222827", "K152448", "K251213", "K152578", "K142683", "K212101", "K050802", "K090993", "K171426", "K183224", "K130726", "K011281", "K211784", "K220023", "K173337", "K183098", "K070947", "K191736", "K150284", "K251324", "K130266", "K043288", "K202571", "K200049" 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"3020331900", "3009161688", "3006149253", "3017636737", "3009217531", "3011390076", "3017820152", "3001675293", "3017119401", "3014309390", "3012811961", "3013283620", "3010432890", "3015153469", "3002681132", "3003537036", "3014579024", "3001592626", "3026606306", "3010885402", "3010860245", "3015224777", "3008615487", "3038188839", "3015612252", "3004784537", "1000512168", "2246552", "3007303113", "3008309062", "3039523130", "3038187466", "3033507886", "3007111496", "3017619652", "3003058448", "3016096100", "3016079756", "3042940623", "3012453745", "3013868968", "3010493171", "3942", "3002259632", "3013665681", "3002680121", "1000499348", "3031594238", "3007593944", "3015241782", "3007029079" ], "device_name": "System, Surgical, Computer Controlled Instrument", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }