FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- Recall number
- Z-0718-2024
- Recalling firm
- Olympus Corporation of the Americas
- Product
- SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
- Status
- Open, Classified
- Initiated
- 2023-12-04
- Posted
- 2024-01-12
- Terminated
- not on file
- Reason
- Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed prior to use) or patient infections (if not noticed prior to use in patient).
- Root cause
- Under Investigation by firm
- Action
- On December 4, 2023, the firm notified affected customers via Urgent Medical Device Removal letters. Customers were instructed to identify and quarantine the affected model/lot. Affected product should not be used. Olympus will issue a credit to customers upon the return of the affected product. If product was distributed outside the customer's facility, the customer should notify those outside facilities immediately. If you require additional information, please contact the company by phone at (647) 999-3203 or by e-mail at Cynthia.Ow@olympus.com.
- Quantity
- 179 units
- Distribution
- Domestic distribution to the following states: AK AR AZ CA FL GA IA ID IN KS KY LA MA MI NC ND NE NJ NY OR PA SC SD TN TX VA WI International distribution to Canada, Latin America, and Europe.
- Lot, serial or model codes
- UDI-DI 00821925043985 Lot KR262848
- 510(k) numbers
- ["K221306"]
- PMA numbers
- not on file
- Product code
- GEX
- 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