{ "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": 3 } }, "results": [ { "cfres_id": "193723", "product_res_number": "Z-1262-2022", "event_date_initiated": "2022-04-20", "event_date_created": "2022-06-13", "recall_status": "Open, Classified", "res_event_number": "90195", "product_code": "FAJ", "k_numbers": [ "K993041" ], "product_description": "Olympus CYSTONEPHROFIBERSCOPE\nModel: CYF-5", "code_info": "UDI-DI: 04953170339417\nSerial Number:\n2456630\n7171632\n2769732\nW501648A\n2355088\n2557155\n2972060", "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": "Incorrect adhesive used to secure the diopter ring and nameplate ring. Improperly connected diopter ring may result in the loss of adjustment function leading to a blurred field of vision and unintentional contact with the patients body and in rare cases perforation in the urinary tract/renal pelvis.", "root_cause_description": "Nonconforming Material/Component", "action": "Olympus notified Urgent Medical Device Correction letter on 4/20/22 via email. Letter states reason for recall, health risk and action to take:\n1.\tIdentify the affected model and serial number in the subject of this letter. The model and serial number can be found on the device as illustrated.\n\n2.\tAn Olympus representative will contact you to make arrangements for return of your affected device. Olympus will repair your unit free of charge. In the meantime, follow the instruction manual for inspection of the device before use. Should any irregularities be identified, including a loose parts, do not use the device and contact Olympus for repair. \n3.\tOlympus will arrange for a service loaner in an effort not to disrupt clinical care. \nContact me directly at 647-999-3203 or at Cynthia.Ow@Olympus.com for any additional information or support concerning this matter.", "product_quantity": "7 units", "distribution_pattern": "CA\nFL\nMA\nMD\nMI\nNJ\nOH\nPR\nWI", "openfda": { "k_number": [ "K930827", "K051176", "K945527", "K250797", "K210512", "K223926", "K941779", "K252176", "K960872", "K170862", "K760179", "K895182", "K222162", "K243653", "K260649", "K902274", "K223040", "K160766", "K992983", "K202921", "K221690", "K012929", "K253905", "K240283", "K060899", "K221683", "K171500", "K221580", "K212202", "K253226", "K021074", "K181909", "K182876", "K860822", "K935278", "K242535", "K943176", "K040215", "K093665", "K231702", "K232837", "K260271", "K240663", "K993041", "K760274", "K980401", "K252598", "K241500", 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