Olympus Thunderbeat II Shears w/Ultrasonic Mode recall (Olympus Corporation of the Americas)
Medical deviceClass IIOngoing
Summary: Olympus Corporation of the Americas is recalling Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.. Reason: Potential for detachment of a distal tip component of the device during use.
What is being recalled
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
Why
Potential for detachment of a distal tip component of the device during use.
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
How to tell if yours is affected
Model Number: TB2-0525FC. UDI-DI: 04953170440007. All Lot Numbers.
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1852-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | March 23, 2026 |
| Reported | April 29, 2026 |
| Company | Olympus Corporation of the Americas |
| Company location | Center Valley, PA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 365 units |
More recalls from Olympus Corporation of the Americas · all medical device recalls · recalls from March 2026