—#204989

Product

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

FDA product code: GEX — Powered Laser Surgical Instrument
Device class: Class 2
Medical specialty: General, Plastic Surgery
510(k) numbers: K221306
Affected lot / code info: UDI-DI 00821925043985 Lot KR262848

Why it was recalled

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 (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm: Olympus Corporation of the Americas
Address: 3500 Corporate Pkwy, Center Valley, Pennsylvania 18034-8229

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2023-12-04
Posted by FDA: 2024-01-12
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #204989. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.