Device recall
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
- Recall number
- Z-3035-2026
- Event id
- 99607
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- Olympus Corporation of the Americas
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Aug 18, 2026
- Center classification date
- Aug 26, 2026
- Product code
- GEI
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Reason
- Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
- Root cause
- Labeling Change Control
- Quantity
- 335 units
- Code info
- Model Number: PS-0523CJDA. UDI-DI: 00821925044531. Lot Number: FR490902.
- Distribution
- Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K212643
- Location
- Center Valley, PA, United States