{ "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": "203663", "product_res_number": "Z-0288-2024", "event_date_initiated": "2023-10-02", "event_date_posted": "2023-11-09", "recall_status": "Open, Classified", "res_event_number": "93212", "product_code": "FDF", "k_numbers": [ "K112680" ], "product_description": "EVIS EXERA III Gastrointestinal Videoscope", "code_info": "Model No. GIF-1TH190; UDI-DI: 04953170343360; All Serial Numbers.", "firm_fei_number": "2429304", "recalling_firm": "Olympus Corporation of the Americas", "address_1": "3500 Corporate Pkwy", "city": "Center Valley", "state": "PA", "postal_code": "18034-8229", "additional_info_contact": "Cynthia Ow\n647-999-3203", "reason_for_recall": "Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.", "root_cause_description": "Reprocessing Controls", "action": "The firm distributed recall notifications via mail to consignees dated 10/02/2023. Consignees are asked to inspect inventory for affected devices, ensure that all reprocessing personnel are aware and knowledgeable of the recall notice and its contents, and acknowledge receipt of the recall notification by returning the enclosed response form via email to olympus5381@sedgwick.com or by fax at 800-913-4345. Customers with any questions about the acknowledgement form are to call 866-912-9544. Customers with any questions about the recall are to contact Cynthia Ow by phone at 647-999-3203 or by email at Cynthia.Ow@Olympus.com.", "product_quantity": "1687 units", "distribution_pattern": "Nationwide Distribution.", "openfda": { "k_number": [ "K160196", "K101191", "K103312", "K102616", "K202469", "K901610", "K070330", "K141598", "K181084", "K113050", "K810682", "K790338", "K132839", "K080317", "K173392", "K951575", "K051541", "K211819", "K954704", "K810654", "K230332", "K130718", "K141286", "K760452", "K260423", "K160356", "K100966", "K190649", "K131780", "K951578", "K210851", "K063654", "K120289", "K100624", "K181437", "K191220", "K244029", "K884857", "K220158", "K153483", "K112680", "K001241", "K052930", "K261587", "K792179", "K032688", "K210052", "K091305", "K220007", "K252457", "K182540", "K162330", "K163492", "K131855", "K961570", "K111756", "K961563", "K101053", "K231254", "K161355", "K192588", "K162428", "K051068", "K081004", "K943895", "K041903", "K801223", "K192664", "K112391", "K161791", "K250432", "K002749", "K111028", "K143732", "K232043", "K242110", "K210981", "K190669", "K230588", "K070622", "K083180", "K091783", "K951580", "K063585", "K172036", "K221452", "K213773", "K140595", "K822846", "K162622", "K121582", "K093037", "K173317", "K023259", "K132210", "K160015", "K090116", "K243261", "K180405", "K180285", "K810791", "K223827", "K232922", "K043487", "K970372", "K093187", "K213578", "K951579", "K242325", "K951574", "K173085", "K171673", "K192793" ], "device_name": "Colonoscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2", "registration_number": [ "", "3010009693", "9611680", "1651395", "3010390468", "2528981", "3042225166", "9681260", "8010047", "3005261802", "3014605202", "3004016520", "1222928", "3015451828", "3003637092", "3011816755", "3002808148", "1000121056", "3013505983", "3013184907", "3004111573", "3006546082", "3009420598", "2950776", "3005814162", "3006161756", "3011416394", "3002808022", "3022106566", "3015525240", "1220477", "3008386005", "2246552", "3010707607", "9610595", "3008879776", "3021246306", "3021008900", "3028058843", "3024021261", "3010288205", "3003775006", "2011171", "3017210488", "3014769442", "3012414760", "3014342096", "9616684", "1528319", "3009698186", "3010703925", "3013944123", "3015136743", "1047843", "3013023255", "3002807314", "3010202439", "3042172882", "3004052101", "3005099803", "3014279513", "3004644065", "3020707080", "9610877", "3023102955", "3010229237", "3008797804", "2020550", "3003782610", "1221826", "3011050570", "3015746529", "9611112", "9610617", "3012843412", "9614641", "3004705634", "3018258446" ], "fei_number": [ "", "1000122656", "3010009693", "3010390468", "3008185830", "2528981", "3042225166", "3005261802", "3014605202", "3004016520", "3015451828", "3003637092", "3011816755", "3002808148", "1000135740", "1000121056", "3013505983", "3013184907", "3007475226", "3004111573", "3006546082", "3009420598", "3005814162", "3011416394", "3002808022", "3022106566", "3008782585", "3015525240", "1220477", "3008386005", "2246552", "3002964398", "3010707607", "3008879776", "3021246306", "3021008900", "3028058843", "3002913962", "3024021261", "3010288205", "3003995201", "3003775006", "3002807969", "2011171", "3017210488", "3014769442", "3012414760", "3002806565", "3014342096", "3002808268", "1000120613", "3009698186", "3010703925", "3013944123", "3015136743", "1047843", "3013023255", "3002807795", "3002807314", "3042172882", "3004052101", "3005099803", "3014279513", "3004644065", "3020707080", "3003012447", "3023102955", "3010229237", "3008797804", "2020550", "3003782610", "1221826", "3011050570", "3015746529", "3002808127", "3012843412", "3004705634", "3018258446" ] } } ] }