Warning
Olympus Corporation of the Americas Recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-1854-2026Medical Device
Olympus Corporation of the Americas Recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode
Olympus Corporation of the Americas · Class II — Moderate Risk
Product Description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 45cm. Model Number: TB2-0545FC.
Reason for Recall
Potential for detachment of a distal tip component of the device during use.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database