{"recall":{"id":"fda-device-99779","source":"FDA","sourceName":"U.S. Food and Drug Administration (openFDA device enforcement)","cat":"medicines","kids":false,"kind":"device","title":"Olympus Corporation of the Americas recalls 2 products","firm":"Olympus Corporation of the Americas","date":"2026-08-24","reported":"2026-10-07","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.","code":"Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.","quantity":"72 units","number":"Z-3299-2026","classification":"Class II"},{"name":"Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.","code":"Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.","quantity":"50 units","number":"Z-3300-2026","classification":"Class II"}],"reason":"There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution to the country of Japan.","nationwide":false,"states":[],"units":"72 units; 50 units","remedy":"","whatToDo":"Check your product against the names and codes above. The FDA enforcement record lists the recall as voluntary: firm initiated; it does not state a consumer remedy, so follow the firm’s notice or the FDA link.","contact":"","url":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99779","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"d059878b7503f95a","firstSeen":"2026-11-02T13:57:14.206Z","updatedAt":"2026-11-02T13:57:14.206Z","history":[]},"official":{"fetchedAt":"2026-11-02T13:57:14.206Z","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","officialUrl":"https://www.accessdata.fda.gov/scripts/ires/index.cfm?Event=99779","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99779","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"International distribution to the country of Japan.","recall_number":"Z-3299-2026","product_description":"Olympus M3 Gold Autoclavable Foroblique Telescope 30. Model Number: M3-30A.","product_quantity":"72 units","reason_for_recall":"There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.","recall_initiation_date":"20260824","center_classification_date":"20260925","report_date":"20261007","code_info":"Model Number: M3-30A. UDI-DI: 00821925005679. All Serial Numbers.","more_code_info":""},{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99779","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"E-Mail","distribution_pattern":"International distribution to the country of Japan.","recall_number":"Z-3300-2026","product_description":"Olympus M3 Gold Autoclavable Lateral Telescope 70. Model Number: M3-70A.","product_quantity":"50 units","reason_for_recall":"There are identified discrepancies between the sterilization parameters listed in the Instructions for Use and the sterilization parameters listed in the Japanese package insert.","recall_initiation_date":"20260824","center_classification_date":"20260925","report_date":"20261007","code_info":"Model Number: M3-70A. UDI-DI: 00821925005686. All Serial Numbers.","more_code_info":""}]}}