| Recall Number | Z-3035-2026 |
|---|---|
| Recalling Firm | Olympus Corporation of the Americas |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan. |
| Status | Ongoing |
| Device Class | N/A |
| Device Name | N/A |
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.