Olympus Corporation Of The Americas: Powerseal 5 Mm (in Diameter) 23 Cm (long), Curved Jaw Sealer & Divider, Double Action. Gei / Electrosurgical, Cutting & Coagulation & Accessories

Recalling firm
Olympus Corporation of the Americas
Product
POWERSEAL 5 MM (in diameter) 23 CM (long), Curved Jaw Sealer & Divider, Double Action. GEI / Electrosurgical, cutting & coagulation & accessories
Reason
Potential labeling deficiency in which an outer shelf box is incorrectly labeled as a 37-cm device.
Classification
Class II
Category
medical device recall
Country
United States
Agency
U.S. Food and Drug Administration
Recall date
2026-08-18
Status
Ongoing
Areas affected
AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
Distribution
Worldwide - US Nationwide distribution in the states of Kansas and Florida. The countries of Australia, European Union, Japan.

Official recall notice from U.S. Food and Drug Administration

Recall details on Nibble Recalls: https://trynibble.app/recalls/f1fdd49a-3e2d-4824-af2d-ffd6c51b1a4c