{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "191859", "product_res_number": "Z-0765-2022", "event_date_initiated": "2021-12-22", "event_date_created": "2022-03-11", "recall_status": "Open, Classified", "res_event_number": "89468", "product_code": "KNS", "k_numbers": [ "K013153" ], "product_description": "JAGTOME REVOLUTION RX 39-20-260-025\n\nMaterial Number: M00584240", "code_info": "Lot Numbers:\n27481920\n27524107\n27525279\n27530542\n27574053\n27598798\n27652479\n27722062\n27722511\n27742261\n27758891\n27795634\n27846706\n27897451\n27969768\n28027118\n28070708\n\nGTIN: 8714729953234", "firm_fei_number": "3005099803", "recalling_firm": "Boston Scientific Corporation", "address_1": "100 Boston Scientific Way", "city": "Marlborough", "state": "MA", "postal_code": "01752-1234", "additional_info_contact": "Brendan Smith \n508-683-4000", "reason_for_recall": "Sterility of device is compromised due to a sterile barrier breach", "root_cause_description": "Packaging process control", "action": "BSC issued Urgent Medical Device Product Removal - Immediate Action Required on\nDecember 16, 2021. Letter states reason for recall, health risk and action to take:\nThe Reply Verification Tracking Form enclosed with this letter must be completed and returned even if you do not have any product from the affected lot/batches.\n1. Immediately discontinue use of and segregate affected product.\n\" Immediately remove all affected product from your inventory.\n\" Segregate this product in a secure location for return to Boston Scientific.\n2. You must complete and email or fax your Reply Verification Tracking Form(s)\nimmediately to get an RGA # before you return any product.\n\" Indicate on your RVTF the quantity of units from each lot/batch that you will be returning.\n\" Return the RVTF as described below:\nEmail: BSCFieldActionCenter@bsci.com\nor\nFax to: Field Action Center 1-866-213-1806\nYou will be contacted by Boston Scientific and provided a Returned Goods Authorization\n(RGA) Number within 24-48 hours after your RVTF is received\n\" Report all inventory to be returned and report in single-unit quantity(ies), not\nboxes.\n\" NOTE: If you have responded to this Removal to anyone other than Boston Scientific,\nwe would not have received your response. Please respond using the email/fax\ninformation provided above. Credits will be issued for all affected product that is properly returned to Boston Scientific.\n3. Package/Ship the Affected Product.\n\" Package any product that is being returned in an appropriate shipping box.\n\" Affix the enclosed (red/white) return address label to the outside of the box.\n\" Write the RGA number in large print on the outside of the box, on the return address\nlabel.\n\" Feel free to use our Federal Express Number 9205-2515-6 to return this package via\nsecond day delivery.\n\" Seal the box, and return to: Boston Scientific Corporation\nUS Distribution Center\nBoston Scientific Marina Bay\nCustomer Fulfillment Center\n500 Commander Shea Blvd.\nQuincy, Massachusetts 0217", "product_quantity": "7115 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of Australia, Austria, Belgium, \nCanada, Botswana, China, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Ireland, Italy, Japan, Korea, Kuwait, Latvia, Lebanon, Mauritius, Morocco, \nNamibia, Netherlands, New Zealand, Norway, Poland, Portugal, Qatar, Romania, Russian Fed., Saudi Arabia, Slovakia, Slovenia, South Africa, Spain, Sweden, Switzerland, \nUnit. Arab Emir.", "openfda": { "k_number": [ "K903323", "K211282", "K990628", "K851096", "K133933", "K913881", "K180165", "K172288", "K171993", "K990376", "K901443", "K862060", "K820405", "K800321", "K192342", "K211909", "K973826", "K082464", "K083292", "K150142", "K972674", "K810336", "K921029", "K884252", "K241855", "K982289", "K031026", "K141991", "K912129", "K052413", "K192905", "K800973", "K961349", "K222421", "K181758", "K003569", "K880748", "K994166", "K260962", "K896612", "K960231", "K912601", "K800965", "K061684", "K802444", "K232476", "K152771", "K030194", "K780774", "K990145", "K982557", "K990852", "K760178", "K861904", "K892895", "K210934", "K860593", "K250351", "K222542", "K946109", "K183595", "K002802", "K150786", "K851958", "K820430", "K800975", "K934315", "K942301", "K092571", "K915408", "K845015", "K160417", "K033135", "K820240", "K851652", "K974168", "K895842", "K942068", "K885005", "K093079", "K812213", "K232633", "K190093", "K232825", "K911648", "K853680", "K233113", 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"K945764", "K052051", "K200404", "K122505", "K193039", "K030315", "K251104", "K896426", "K896507", "K864413" ], "device_name": "Unit, Electrosurgical, Endoscopic (With Or Without Accessories)", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.4300", "device_class": "2", "registration_number": [ "", "9610617", "1222140", "3015975397", "3010707607", "3004837686", "3005099803", "3009217531", "3013557681", "1825146", "1057358", "9610612", "9680515", "3003902943", "2124215", "3013247477", "3009183442", "3011050570", "3035434483", "3021171301", "3006950086", "1828132", "1651252", "3010202439", "3008720584", "3013440400", "2650143", "3007305485", "3002807314", "3014769442", "3004215117", "3006696607", "2936485", "1000121056", "1225687", "3018094310", "3015286855", "3002806337", "3004111573", "9616684", "9611102", "2133936", "3015309643", "3003724334", "9614641", "3009526575", "3031233199", "3014342096", "3003790304", "1649518", "9612074", "3010288205", 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