Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
FDA device recall Z-1852-2026 · posted 2026-04-17 · Open, Classified
Recall details
- Recalling firm
- Olympus Corporation of the Americas
- Reason for recall
- Potential for detachment of a distal tip component of the device during use.
- Action taken
- Olympus notified consignees on about 03/23/2026 via emailed letter. Consignees were instructed to immediately cease use of all THUNDERBEAT II devices, examine inventory for affected product and quarantine any on hand, and complete, return the Reply Form provided and arrange for the return of all affected units in inventory. Consignees were also instructed to notify other users if the affected products were transferred or further distributed.
- Root cause
- Device Design
- Status
- Open, Classified
- Product code
- GEI
- Quantity affected
- 365 units
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Date initiated
- 2026-03-23
- Date posted
- 2026-04-17
- Location
- Center Valley, PA
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