Olympus Corporation of the Americas SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Brand
Olympus Corporation of the Americas
Lot Codes / Batch Numbers
UDI-DI 00821925043985 Lot KR262848
Products Sold
UDI-DI 00821925043985 Lot KR262848
Olympus Corporation of the Americas is recalling SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS due to Affected products may potentially have a breached sterile pouch seal. A breached sterile pouch seal may lead to minor procedure delays (if noticed pri. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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).
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AK, AZ, AR, CA, FL, GA, ID, IN, IA, KS, KY, LA, MA, MI, NE, NJ, NY, NC, ND, OR, PA, SC, SD, TN, TX, VA, WI
Page updated: Jan 10, 2026