Class II

Medical Device Recall: Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940

Olympus Corporation of the Americas · December 4, 2023

Reason for Recall

The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a sterile fiber poses a risk of contamination.

Distribution

US Nationwide. Global Distribution

States Affected

NATIONWIDE

Quantity Affected

3001 units

Source: FDA (openFDA Device Enforcement)

Recall number: Z-0716-2024

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.