{"recall":{"id":"fda-device-99627","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 Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11","firm":"Olympus Corporation of the Americas","date":"2026-08-19","reported":"2026-09-30","status":"Ongoing","classification":"Class II","products":[{"name":"Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.","code":"Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.","quantity":"305 units","number":"Z-3216-2026","classification":"Class II"}],"reason":"Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"International distribution in the country of Japan.","nationwide":false,"states":[],"units":"305 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=99627","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"c399f747fc2ba8a9","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=99627","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99627","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 in the country of Japan.","recall_number":"Z-3216-2026","product_description":"Olympus EZDilate Endoscopic Balloon Dilator Wired-guided 11, 12, 13mm. Model Number: BD-420X-1355.","product_quantity":"305 units","reason_for_recall":"Potential for the inflation chart label affixed to the shaft of the device to be incorrect and indicate a balloon diameter of 18, 19, or 20 mm,","recall_initiation_date":"20260819","center_classification_date":"20260918","report_date":"20260930","code_info":"Model Number: BD-420X-1355. UDI-DI: 00821925042261. Lot Number: 460898.","more_code_info":""}]}}