Medical Device Recall: SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS
Olympus Corporation of the Americas · December 4, 2023
Reason for Recall
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).
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.
States Affected
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
Quantity Affected
179 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0718-2024
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.