{"recall":{"id":"fda-device-99607","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 POWERSEAL 5 MM (in diameter) 23 CM (long)","firm":"Olympus Corporation of the Americas","date":"2026-08-18","reported":"2026-09-02","status":"Ongoing","classification":"Class II","products":[{"name":"POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories","code":"Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.","quantity":"335 units","number":"Z-3035-2026","classification":"Class II"}],"reason":"Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.","hazard":"FDA Class II: may cause temporary or medically reversible adverse health consequences (FDA definition).","affected":"Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.","nationwide":true,"states":[],"units":"335 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=99607","apiUrl":"https://api.fda.gov/device/enforcement.json?search=report_date:[20260705+TO+20991231]&sort=report_date:desc&limit=1000","rawHash":"00ac44b3032fa5e2","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=99607","record":[{"status":"Ongoing","city":"Center Valley","state":"PA","country":"United States","classification":"Class II","openfda":{},"product_type":"Devices","event_id":"99607","recalling_firm":"Olympus Corporation of the Americas","address_1":"3500 Corporate Pkwy","address_2":"N/A","postal_code":"18034-8229","voluntary_mandated":"Voluntary: Firm initiated","initial_firm_notification":"Letter","distribution_pattern":"Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.","recall_number":"Z-3035-2026","product_description":"POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.    GEI / Electrosurgical, cutting & coagulation & accessories","product_quantity":"335 units","reason_for_recall":"Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.","recall_initiation_date":"20260818","center_classification_date":"20260826","report_date":"20260902","code_info":"Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902."}]}}