{ "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": "2026-09-05", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "218985", "product_res_number": "Z-1855-2026", "event_date_initiated": "2026-03-11", "event_date_posted": "2026-05-01", "recall_status": "Open, Classified", "res_event_number": "98525", "product_code": "NAY", "k_numbers": [ "K211997", "K222839", "K241638" ], "product_description": "Intuitive 8 mm SureForm 30 Gray Reloads \nReference Numbers: 48230M-05 and 48230M-06", "code_info": "UDI:00886874121931/All serial Numbers", "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": "Customer Service\n1800-876-1310 Ext. 3", "reason_for_recall": "Reloads for curved-tipped stapler may potentially produce an incomplete staple line.", "root_cause_description": "Under Investigation by firm", "action": "On 3/17/2026 Intuitive Surgical issued a \"urgent Medical Device Recall Notification to affected consignees via E.Mail and FedEx. Intuitive ask consignees to take the following actions:\n\n1.\tPlease identify, discontinue use, and quarantine any affected product(s). Affected product(s) may be returned by calling customer service with quantities and lot numbers to your regional customer service.\n2.\tComplete the attached Acknowledgement Form immediately and return it via fax or email to Intuitive as instructed on the form. \n3.\tPlease ensure to include the Recall or FSCA number ISIFA2026-02-R in your return notes.\n4.\tIf you have shared or further distributed these products with other sites, please make sure appropriate staff at the site receive and understand this notification so they locate and return their affected product.", "distribution_pattern": "US: Alabama\tAlaska\tArizona\tArkansas\tCalifornia\tColorado\tConnecticut\tDelaware\tDistrict of Columbia\tFlorida\tGeorgia\tHawaii\tIdaho\tIllinois\tIndiana\tIowa\tKansas\tKentucky\tLouisiana\tMaine\tMaryland\tMassachusetts\tMichigan\tMinnesota\tMississippi\tMissouri\tMontana\tNebraska\tNevada\tNew Hampshire\tNew Jersey\tNew Mexico\tNew York\tNorth Carolina\tNorth 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