Class II
Medical Device Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Olympus Corporation of the Americas · March 23, 2026
Reason for Recall
Potential for detachment of a distal tip component of the device during use.
Distribution
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
States Affected
IN
Quantity Affected
3,360 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1853-2026
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.