{ "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": "204021", "product_res_number": "Z-0415-2024", "event_date_initiated": "2023-10-16", "event_date_posted": "2023-11-29", "recall_status": "Open, Classified", "res_event_number": "93335", "product_code": "FDF", "k_numbers": [ "K131780" ], "product_description": "CF-HQ190L EVIS EXERA III COLONOVIDEOSCOPE", "code_info": "UDI-DI 04953170305115\nSerial Numbers 2635812, 2416423", "firm_fei_number": "3002964398", "recalling_firm": "Aizu Olympus Co., Ltd.", "address_1": "3 Chome 1-1 1-1 Niiderakita", "city": "Aizuwakamatsu", "state": "3 Chome", "country": "Japan", "additional_info_contact": "Cynthia Ow\n647-9993203", "reason_for_recall": "Specific devices may have an improperly repaired light guide connector due to missing adhesive to secure the suction channel mouthpiece to the scope connector. Issue may result in loss of image, decreased suction, or impact the ability to effectively reprocess the device. This in turn may lead to unanticipated delay to treatment, or patient exposure to contaminated material and subsequent infection.", "root_cause_description": "Process control", "action": "On October 16, 2023, the firm notified affected customers through URGENT MEDICAL DEVICE REMOVAL letters. Customers were instructed to inspect their inventory and identify affected devices. Affected devices should be quarantined and not used.\n\nOlympus Customer Solutions will contact customers by phone and email to arrange the return and repair of the affected product.\n\nIf you require additional information, please do not hesitate to contact Olympus at 647-999-3203 or Cynthia.Ow@Olympus.com.", "product_quantity": "24 incorrectly repaired units", "distribution_pattern": "Domestic distribution to FL, KY, MA, NJ, NY, and PA", "openfda": { "k_number": [ "K242110", "K970372", "K884857", "K232922", "K051541", "K102616", "K901610", "K951579", "K954704", "K250432", "K172036", "K101053", "K080317", "K153483", "K213773", "K070330", "K101191", "K173317", "K171673", "K173392", "K091783", "K041903", "K220007", "K083180", "K111756", "K260423", "K182540", "K951574", "K161355", "K121582", "K132839", "K223827", "K192588", "K160015", "K181084", "K162428", "K141286", "K810791", "K943895", "K090116", "K213578", "K210851", "K244029", "K131855", "K231254", "K081004", "K130718", "K192664", "K951575", "K043487", "K951578", "K192793", "K052930", "K023259", "K132210", "K190669", "K140595", "K143732", "K261587", "K801223", "K810654", "K230332", "K112391", "K113050", "K100966", "K160356", "K162622", "K810682", "K141598", "K191220", "K063585", "K163492", "K961563", "K103312", "K790338", "K001241", "K093187", "K093037", "K180285", "K190649", "K230588", "K112680", "K252457", "K063654", "K221452", "K173085", "K961570", "K100624", "K951580", "K091305", "K111028", "K032688", "K760452", "K822846", "K161791", "K162330", "K202469", "K210981", "K242325", "K232043", "K220158", "K120289", "K210052", "K131780", "K211819", "K181437", "K070622", "K792179", "K002749", "K243261", "K051068", "K180405", "K160196" ], "registration_number": [ "", "1220477", "1222928", "3015136743", "3008386005", "9611680", "9681260", "9610877", "3005099803", "2528981", "3028058843", "3023102955", "3022106566", "3021246306", "3008879776", "3004111573", "3002807314", "3005261802", "3011416394", "3020707080", "3012843412", "2011171", "3004016520", "3012414760", "3013505983", "3042172882", "3010009693", "3009420598", "3010390468", "3014769442", "3003775006", "3014342096", "3021008900", "3015451828", "3004052101", "8010047", "3008797804", "3004644065", "3003782610", "3042225166", "3013944123", "3002808022", "1000121056", "3002808148", "9610595", "9616684", "3013184907", "3010288205", "3011816755", "1528319", "2020550", "3010202439", "3024021261", "3006546082", "3015525240", "2246552", "1047843", "3017210488", "3005814162", "3018258446", "3010229237", "1651395", "3011050570", "2950776", "3014279513", "9611112", "3015746529", "3003637092", "3010707607", "3006161756", "9614641", "1221826", "9610617", "3014605202", "3009698186", "3013023255", "3004705634", "3010703925" ], "fei_number": [ "", "1220477", "3015136743", "3008386005", "3005099803", "2528981", "3028058843", "3023102955", "3002806565", "3022106566", "3021246306", "3008879776", "3002808268", "3004111573", "3002807314", "1000122656", "3011416394", "3005261802", "3020707080", "3012843412", "2011171", "3004016520", "3012414760", "3013505983", "3042172882", "3010009693", "3009420598", "3010390468", "3014769442", "3003775006", "3014342096", "3021008900", "3008782585", "3015451828", "3002807969", "3004052101", "3008797804", "3004644065", "3002913962", "3003782610", "3042225166", "3013944123", "3002808022", "1000121056", "3002808148", "3007475226", "3003995201", "3013184907", "3010288205", "3011816755", "2020550", "3024021261", "3006546082", "3015525240", "3003012447", "2246552", "3008185830", "1047843", "1000120613", "3017210488", "3005814162", "3018258446", "3010229237", "3011050570", "3014279513", "3015746529", "1000135740", "3002807795", "3003637092", "3002964398", "3010707607", "1221826", "3014605202", "3009698186", "3013023255", "3002808127", "3010703925", "3004705634" ], "device_name": "Colonoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }