Warning
Olympus Corporation of the Americas Recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm
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-1851-2026Medical Device
Olympus Corporation of the Americas Recalls Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm
Olympus Corporation of the Americas · Class II — Moderate Risk
Product Description
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
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.
411 Press Analysis
The FDA classified this recall as Class II, indicating the medical device may cause temporary health problems or poses a slight threat of a serious nature. Olympus Corporation of the Americas initiated the recall on March 23, 2026 affecting 830 units. Potential for detachment of a distal tip component of the device during use. The product was distributed internationally, including the United States. Consumers should check their purchases and discontinue use of any affected product. Contact Olympus Corporation of the Americas for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Medical Device Defects and Olympus recalls.