Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
SOLTIVE SuperPulsed Laser Fibers Recalled by Olympus Corporation of the Americas Due to Affected products may potentially have a breached sterile...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Olympus Corporation of the Americas directly.
Affected Products
SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Quantity: 179 units
Why Was This 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).
Where Was This Sold?
This product was distributed to 27 states: 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
About Olympus Corporation of the Americas
Olympus Corporation of the Americas has 378 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report