Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0716-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: December 4, 2023

Date Posted: January 24, 2024

Recall Number: Z-0716-2024

Event ID: 93613

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.

Status: Ongoing

Product Quantity: 3001 units

Code Information:

Lot Number: All units sold prior to 2023

Distribution Pattern:

US Nationwide. Global Distribution

Voluntary or Mandated:

Voluntary: Firm initiated