{"url_path":"/fda/device/recalls/Z-3035-2026","section_key":"summary","section_title":"DEVICE Recall: Olympus Corporation of the Americas — POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.    GEI / Electrosurgical, cutting & coagulation & accessories","topic":"fda","document":{"doc_type":"device-recall","doc_date":"2026-08-18","source_url":"https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3035-2026%22","accession_number":null,"cik":null,"ticker":null,"issuer_name":null,"edgar_url":null,"primary_entity_key":null,"primary_entity_name":"Olympus Corporation of the Americas"},"word_count":101,"has_tables":false,"body_markdown":"# FDA DEVICE Recall: Z-3035-2026\n\n**Recalling firm:** Olympus Corporation of the Americas\n**Classification:** Class II\n**Status:** Ongoing\n**Type:** Voluntary: Firm initiated\n**Initiated:** 2026-08-18\n**Report date:** 2026-09-02\n\n## Product\nPOWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action.    GEI / Electrosurgical, cutting & coagulation & accessories\n\n## Reason\nPotential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.\n\n## Affected lots\nModel Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.\n\n## Distribution\nWorldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan."}