FDA-Device2026-09-02Class IIMISBRANDING
Olympus POWERSEAL 5mm curved jaw sealer recalled for incorrect device length labeling
What this means
Olympus Corporation of the Americas is recalling POWERSEAL 5mm curved jaw sealer and divider devices due to incorrect labeling on the outer box. Some units labeled as 37 cm devices actually contain 23 cm devices, which could lead to confusion during surgical use. The issue affects 335 units distributed in the US, Australia, the European Union, and Japan.
- Check the outer box label on your POWERSEAL device (Model PS-0523CJDA, Lot FR490902).
- Verify the actual device length (23 cm) matches your intended surgical use.
- Contact Olympus Corporation of the Americas if you have questions about your device.
The agency's original wording
Hazard
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Intended for
Adults
Illnesses reported
None reported
Sold states
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.
Affected count
335 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3035-2026More Olympus recalls
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