{ "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": 2 } }, "results": [ { "cfres_id": "220248", "product_res_number": "Z-2402-2026", "event_date_initiated": "2026-04-29", "event_date_posted": "2026-06-11", "recall_status": "Open, Classified", "res_event_number": "98939", "product_code": "GXI", "k_numbers": [ "K050084", "K183177" ], "product_description": "Boston Scientific CSK Electrodes:\nREF: CSK-TC10, CSK Electrode, STAINLESS STEEL, 10 cm x 28 ga (0.36 mm)\nREF: CSK-TC10-3M,CSK Electrode, STAINLESS STEEL, 3M Cable, 10 cm x 28 ga (0.36 mm);\nREF: CSK-TC15, CSK Electrode, STAINLESS STEEL, 15 cm x 28 ga (0.36 mm);\nREF: CSK-TC15-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 15 cm x 28 ga (0.36 mm)\nREF: CSK-TC20, CSK Electrode, STAINLESS STEEL, 20 cm x 28 ga (0.36 mm)\nREF: CSK-TC5,CSK Electrode, STAINLESS STEEL, 5 cm x 28 ga (0.36 mm);\nREF: CSK-TC5-3M, CSK Electrode, STAINLESS STEEL, 3M Cable, 5 cm x 28 ga (0.36 mm)", "code_info": "All Lots: / UDI: \nCSK-TC10:00813250010107;\nCSK-TC10-3M: 00813250011524;\nCSK-TC15 00813250010114;\nCSK-TC15-3M: 00813250011548\nCSK-TC20: 0081325001140;\nCSK-TC5: 00813250010091;\nCSK-TC5-3M: 00813250011531;", "firm_fei_number": "3006630150", "recalling_firm": "Boston Scientific Neuromodulation Corporation", "address_1": "25155 Rye Canyon Loop", "city": "Valencia", "state": "CA", "postal_code": "91355-5004", "additional_info_contact": "Renee Archie\n661-949-4000", "reason_for_recall": "Reusable electrodes may not meet expected performance levels.", "root_cause_description": "Under Investigation by firm", "action": "On April 29, 2026, Boston Scientific issued a Urgent Medical device Removal Notification via Federal Express/email/hand delivery. Boston Scientific asked consignees to take the following actions:\n\n1. DO NOT use affected product. Remove affected products from your facility s inventory, and segregate the units in a secure place.\n\n2. For products already in use, immediately discard according to your facility s procedure.\n\n3. Unused products should be returned to Boston Scientific in accordance with the enclosed instructions.\n\n4. Immediately post this information in a visible location near the affected products to ensure this information is readily accessible to all handlers and users of the device.\n\n5. Forward this notice to any healthcare professional from your organization for awareness and to any organization where affected devices have been transferred.\n\n6. Complete and return the enclosed Reply Verification Tracking Form per the enclosed instructions.", "product_quantity": "31,923 units", "distribution_pattern": "Worldwide distribution - US Nationwide and the countries of PE, MX, PR, CO, MY, CA.", "openfda": { "k_number": [ "K191293", "K152642", "K884347", "K050084", "K053415", "K101372", "K001588", "K991399", "K032196", "K141586", "K802243", "K053082", "K163461", "K170708", "K000073", "K163236", "K042375", "K190504", "K080771", "K994344", "K071300", "K180369", "K242841", "K880293", "K032406", "K112231", "K250213", "K222281", "K980430", "K203066", "K062946", "K251802", "K090608", "K092337", "K021942", "K153272", "K213836", "K041021", "K880925", "K060397", "K251243", "K060799", "K011387", "K170827", "K880951", "K043442", "K190256", "K062937", "K972846", "K082012", "K183177", "K002389", "K071745", "K110593", "K241367", "K150371", "K253907", "K090955", "K121773", "K882802", "K870028", "K034012", "K190259", "K123178", "K102566", "K063467" ], "registration_number": [ "3010966701", "3017423051", "3004122598", "1319639", "1030489", "2124215", "3007695959", "2133786", "3005941719", "3004762958", "9616662", "1222773", "3015967359", "9611665", "3006950086", "3003365815", "3007997036", "3033589330", "3008102042", "3010273872", "1644312", "3004617090", "3005160949", "2183744", "3009732568", "3010034260", "1720929", "3003477135", "9680425", "9616693", "3015309643", "3013302242", "3007221462", "3015924373", "3007029079", "3029990829", "1000632857", "3013111980", "1721504", "9680001", "3008534770", "1450662", "1643817", "3005334138", "3015443199", "1316297", "3008998256", "2182269", "3030733800", "1526711", "3006630150", "1313525", "8010177", "1627487", "1928237", "9611612", "3004785273", "2030624", "3011270181", "3020968442", "3008837339", "3016438686", "3012536737", "1225687", "2032521", "3021008900", "3018094310", "1221485", "3009766315", "1721983", "8043398", "1643059", "3008559295", "3009823392", "2029275", "3016678045", "1721676", "3015173212", "1000121056", "1224960", "3043527620", "3009241989", "3003120897", "1920664", "2182979" ], "fei_number": [ "3010966701", "3002618605", "3017423051", "3004122598", "1000064530", "2124215", "3002807095", "3007695959", "3003574398", "3002807111", "3002807847", "3004762958", "3015967359", "1000306431", "3006950086", "3003365815", "3007997036", "3033589330", "3010273872", "1000117748", "3004617090", "3005160949", "3000204692", "3000335778", "3002821504", "2183744", "3009732568", "3010034260", "1720929", "3003477135", "1000138054", "3015309643", "3013302242", "1000477302", "3007221462", "3002808445", "3015924373", "3007029079", "3029990829", "1000632857", "3013111980", "1721504", "3008534770", "3000206435", "3003630373", "1450662", "1643817", "3005334138", "3015443199", "1316297", "3008998256", "2182269", "3030733800", "1526711", "3002924544", "3006630150", "1627487", "1928237", "3004785273", "1000120768", "3011270181", "3020968442", "3008837339", "3016438686", "3012536737", "1317628", "3021008900", "3018094310", "1221485", "3009766315", "1643059", "3008559295", "3009823392", "3016678045", "1721676", "3015173212", "3007596547", "1000121056", "3000204727", "3043527620", "3009241989", "3003120897", "1920664", "3001451463", "2182979" ], "device_name": "Probe, Radiofrequency Lesion", "medical_specialty_description": "Neurology", "regulation_number": "882.4725", "device_class": "2" } } ] }