Class IIDeviceOngoing

Olympus Corporation of the Americas

POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories

Reason for recall

Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.

Details

Recall number: Z-3035-2026
Event ID: 99607
Recall initiated: Aug 18, 2026
Classified: Aug 26, 2026
Reported: Sep 2, 2026
Quantity: 335 units
Distribution: Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Initiated by: Voluntary: Firm initiated
Firm notification: Letter
Firm location: Center Valley, PA, United States
Lot / code info: Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.