FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- Recall number
- Z-1852-2026
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus Thunderbeat II Shears w/Ultrasonic Mode, 5mm, 25cm. Model Number: TB2-0525FC.
- Status
- Open, Classified
- Initiated
- 2026-03-23
- Posted
- 2026-04-17
- Terminated
- not on file
- Reason
- Potential for detachment of a distal tip component of the device during use.
- Root cause
- Device Design
- Action
- 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.
- Quantity
- 365 units
- Distribution
- International distribution in the countries of Australia, Japan, Hong Kong, and Europe.
- Lot, serial or model codes
- Model Number: TB2-0525FC. UDI-DI: 04953170440007. All Lot Numbers.
- 510(k) numbers
- ["K252150"]
- PMA numbers
- not on file
- Product code
- GEI
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28