FDA DevicesClass II
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-05...
Published: April 29, 2026Recall ID: Z-1853-2026Category: devicesCountry: US
Reason for Recall / Hazard
Potential for detachment of a distal tip component of the device during use.
Product Description & Identification
Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 35cm. Model Number: TB2-0535FC.
Additional Source Details
| Field | Value |
|---|---|
| City | Center Valley |
| State | PA |
| Event id | 98550 |
| Address 1 | 3500 Corporate Pkwy |
| Address 2 | N/A |
| Code info | Model Number: TB2-0535FC. UDI-DI: 04953170440014. All Lot Numbers. |
| Postal code | 18034-8229 |
| Report date | 20260429 |
| Product type | Devices |
| Product quantity | 3,360 units |
| Reason for recall | Potential for detachment of a distal tip component of the device during use. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260323 |
| Initial firm notification | |
| Center classification date | 20260417 |
Overview
- Recalling FirmOlympus Corporation of the Americas
- StatusOngoing
- Risk LevelClass II
- DistributionInternational distribution in the countries of Australia, Japan, Hong Kong, and Europe.