FDA Medical devices recall ·
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm recall
- Recall number
- Z-1852-2026
- Date
- (initiated March 23, 2026)
- Company / brand
- Olympus Corporation of the Americas
3500 Corporate Pkwy, Center Valley, PA, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 365 units
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Why was it recalled?
Potential for detachment of a distal tip component of the device during use.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Model Number: TB2-0525FC. UDI-DI: 04953170440007. All Lot Numbers.
Distribution
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-1852-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.