HIGH

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.

Potential for detachment of a distal tip component of the device during use.

Quick Facts at a Glance

Recall Date
March 23, 2026
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas

Hazard Information

Potential for detachment of a distal tip component of the device during use.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: E-Mail

Get instant alerts for Olympus Corporation of the Americas recalls

Be the first to know. Free instant alerts to your inbox.

No spamUnsubscribe anytime

Full Description

Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.. Reason: Potential for detachment of a distal tip component of the device during use.. Classification: Class II. Quantity: 3,360 units. Distribution: International distribution in the countries of Australia, Japan, Hong Kong, and Europe.

View Original Recall on FDA - Medical Devices

Browse More Recalls

More from FDA_DEVICEHealth & Personal CareMedical Devices

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: How to Get Refunds and Replacements

Want to Know First?

Get instant alerts for recalls that affect you. Free forever.

Product Classification

Product Details

Model Numbers
Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers.
Report Date
April 29, 2026
Recall Status
ACTIVE

Related Recalls