Class II — Olympus Corporation of the Americas
| Recalling firm | Olympus Corporation of the Americas |
|---|---|
| Classification | Class II |
| Status | Ongoing |
| Reason | Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device. |
| Product | POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories |
| Quantity | 335 units |
| Distribution | Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan. |
| Initiated | 2026-08-18 |
| Classified | 2026-08-26 |
| Recall number | Z-3035-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Olympus Corporation of the Americas (Z-3035-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99607/
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