Official recall notice
FDA DeviceClass IINotable
FDA Recall: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 20cm. Model Number: TB2-0520FC.
- Recall date
- 2026-04-29
- Category
- Medical Device
- FDA class
- Class II
Why it was recalled
Hazard
Potential for detachment of a distal tip component of the device during use.
Recommended action
What to do
830 units
Product description
Potential for detachment of a distal tip component of the device during use.