{ "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": "2026-08-15", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "167918", "product_res_number": "Z-0234-2019", "event_date_initiated": "2018-09-14", "event_date_created": "2018-10-24", "recall_status": "Terminated", "event_date_terminated": "2021-02-12", "res_event_number": "81244", "product_code": "PUI", "product_description": "Disposable Accessory Kit, 4-Arm (Box of 5) individually sealed in poly-Tyvek pouches / Rx Sterile / to used exclusively on the Intuitive Surgical Da Vinci Si Robotic system / Distributed by Intuitive Surgical\n\nProduct Usage:\nMicrotek Medical Equipment Drapes are intended to cover/wrap various surgical and/or nonsurgical instruments/equipment [e.g. robotic arms, microscopes, tables, x ray systems, light handles, etc]. They function as a physical barrier to prevent cross contamination between the instrument / equipment and medical staff and/or to allow the instrument/equipment to enter a hygienic area [e.g. sterile surgical field] in various clinical settings. They are typically made of flexible plastic and shaped to fit the type of instrument / equipment. They are a single use device [not to be reprocessed]", "code_info": "Item 420291-03 Lot # D173147, D173177, D173517, D173437, D173487, D172937, D173407, D173417, D173317, D180117, D180177, D173477, D180087, D173187, D173137, D172987, D173217, D173067, D173497, D173447, D173427, D173287, D180167, D180027, D173577, D173077, D180097, D180157, D173627, D173607, D173467, D173567, D180197, D173257, D173637, D173457, D180267, D180257, D172997, D173547, D180317, D180237, D173227, D173537, D173507, D180107, D173617, D173267, D180247, D173197, D180057, D180187, D180347, D180337, D180377, D180037, D180307, D180437, D173017,and D180507.", "firm_fei_number": "3014342658", "recalling_firm": "Ecolab Inc", "address_1": "1 Ecolab Pl", "city": "Saint Paul", "state": "MN", "postal_code": "55102-2739", "additional_info_contact": "Roman Blahoski\n651-250-4385", "reason_for_recall": "The pouches of certain lots of product may have wrinkles along the pouch seal that could result in a channel within the seal. Should there be a channel in the pouch seal it may result in a breach in the sterility of the product.", "root_cause_description": "Under Investigation by firm", "action": "Intuitive sent a communication letter to all their consignees with the following instructions:\nActions to be taken by the Customer/User\nPlease take the following Actions:\n1. Locate and return all drapes with the affected part numbers and lots to Intuitive Surgical.\n2. Inform affected personnel when the correction has been completed.\n3. Please log into the da Vinci Online Community Field Action resource to read or complete any requested actions related to this issue, at this link:\nhttps://www.davincisurgerycommunity.com/\n4. In the case where the da Vinci online resource cannot be used, complete the attached Acknowledgement Form and return it via fax to Intuitive Surgical as instructed on the form.\n5. Please retain a copy of this letter and the acknowledgement form for your files.\nActions to be taken by Intuitive Surgical\n1. Intuitive Surgical representatives will be available by phone to answer any questions related to this Medical Device Correction.\n2. Credit up to the nearest full box will be provided for the return of affected product.\n\nIf you need further information or support concerning this Medical Device Notification , please contact your Clinical Sales Representative or contact Intuitive Surgical 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 ics@intusurg.com", "product_quantity": "9,364 cases (46,820 eaches)", "distribution_pattern": "Worldwide - US Nationwide Distribution in the states of AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, AND WY\nIn the countries of Argentina, Australia, Austria, Belgium, Canada, Chile, China, Colombia, Czech Republic, Denmark, Finland, France, Germany, Guadeloupe, Iceland, Ireland, Italy, Martinique, Netherlands, Norway, Russian Federation, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, and United Kingdom", "openfda": { "registration_number": [ "3011767135", "3007407626", "3004911384", "3006437555", "3014925393", "3008331349", "2320762", "3023191945", "3044819802", "3017884667", "3022085015", "3005841027", "3017425975", "2921578", "3011862887", "3011063460", "3007139365", "3003951061", "9612354", "3013006775", "3012345110", "3017896194", "9616088", "3030067857", "3010827261", "9612030", "3005748481", "3006847952", "3030626857", "3031233007", "3017838287", "3010375076", "3045816907", "9610612", "8043933", "3012966700", "3006400329", "3005400762", "3007007790", "3016452400", "3009702671", "3007697249", "3013659199", "1030451", "3014747754", "3004022422", "3006210673", "3010305275", "3013557562", "1650907", "3008102042", "9614277", "1037885", "3030645716", "1226544", "3011494917", 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