{ "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": "2026-09-12", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "193859", "product_res_number": "Z-1275-2022", "event_date_initiated": "2022-04-22", "event_date_created": "2022-06-21", "recall_status": "Open, Classified", "res_event_number": "90232", "product_code": "FDS", "product_description": "EVIS EXERA II Gastrointestinal Videoscope-indicated for use within the upper digestive tract (including the esophagus, stomach, and duodenum).\nModel: GIF-HQ190", "code_info": "UDI-DI: 04953170305276\nSerial: 2269931, 2611873, 2613235, 2634251, 2634326, 2860721, 2961773 and 2962545", "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": "SAME\n484-896-5000", "reason_for_recall": "Part (A-rubber) intended for a different model of gastrointestinal videoscope may have been used when\nreplacing part on GIF-HQ190 during the last repair at Olympus. An Incorrect A-rubber fits tighter on the GIF-HQ190 which would not meet the intended design specifications", "root_cause_description": "Nonconforming Material/Component", "action": "Olympus issued Urgent Medical Device Correction letter via email on 4/22/22. Letter states reason for recall, health risk and action to take:\n1. Identify the affected model and serial number in the subject of this letter.\n2. An Olympus representative will contact you to arrange for the return of your affected\ndevice. Olympus will repair your unit free of charge.\n3. Olympus will provide for a service loaner in an effort to not disrupt patient care.\n\nPlease do not hesitate to contact @ 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.", "product_quantity": "8 units", "distribution_pattern": "US Nationwide distribution in the states of AL, FL, NC, NY.", "openfda": { "k_number": [ "K093779", "K011151", "K142629", "K251256", "K210162", "K131902", "K123317", "K063847", "K253702", "K210177", "K183572", "K180341", "K243512", "K213606", "K181763", "K961564", "K260824", "K221551", "K850020", "K833924", "K260856", "K242635", "K152182", "K182836", "K180911", "K180292", "K063316", "K251041", "K001766", "K113166", "K183686", "K251708", "K153206", "K212382", "K971660", "K240142", "K120446", "K250296", "K193123", "K013640", "K984358", "K173004", "K250550", "K232919", "K232028", "K242779", "K974493", "K971734", "K260573", "K140295", "K232314", "K190799", "K212296", "K162749", "K250900", "K032177", "K962460", "K243388", "K131422", "K042043", "K210915", "K021886", "K963023", "K002231", "K832007", "K253568", "K060907", "K241213", "K192704", "K232997", "K933717", "K943715", "K111243", "K172916", "K130148", "K210485", "K962897", "K200850" ], "registration_number": [ "3015136743", "3004837686", "8010047", "3010141954", "3021691063", "3004644065", "3013247477", "3010703925", "9617070", "3015525240", "3009698186", "3014605202", "3010202439", "3011193403", "3010707607", "3014342096", "9611112", "3011816755", "3003790304", "3015807001", "3005099803", "3003775006", "3042172882", "9610877", "3010288205", "3042225166", "3015746529", "3021246306", "1450997", "3015194986", "3044545674", "3004040397", "3013440400", "3024021261", "3008627763", "3008797804", "1528319", "3013944123", "3010220595", "3015223550", "2020550", "2183744", "3006161756", "3015131155", "3003782610", "3004705634", "3009171251", "3011050570", "3012843412", "3018258446", "3017140456", "3010188783", "3010390468", "9614641", "9610691", "3015451828", "3043226252", "3011416394", "3014769442", "1649518", "3008386005", "3012494290", "3002808148", "1221826", "3002807310", "3013023255", "9611680", "3004111573", "9610595", "9610617" ], "fei_number": [ "3015136743", "3004837686", "3004644065", "3010141954", "3021691063", "3013247477", "3010703925", "3002806359", "3007475226", "3009698186", "3015525240", "3014605202", "3010707607", "3011193403", "3014342096", "3003790304", "3011816755", "3015807001", "3002808127", "3005099803", "3003775006", "3042172882", "3010288205", "3042225166", "3008782585", "3015746529", "3021246306", "1450997", "3015194986", "3044545674", "3004040397", "3013440400", "3024021261", "3008627763", "3008797804", "3013944123", "3010220595", "3015223550", "2020550", "2183744", "3008185830", "3015131155", "3006759904", "3003782610", "3004705634", "3011050570", "3002964398", "3012843412", "3018258446", "3017140456", "3010188783", "3010390468", "3002807795", "3015451828", "3043226252", "3011416394", "3014769442", "3008386005", "3012494290", "3002808148", "1221826", "3002807969", "3002807310", "3013023255", "3002807134", "1000122656", "3004111573", "3001236277", "3002808268", "3003995201" ], "device_name": "Gastroscope And Accessories, Flexible/Rigid", "medical_specialty_description": "Gastroenterology, Urology", "regulation_number": "876.1500", "device_class": "2" } } ] }