Olympus Corporation of the Americas: Medical Device Recall in 2024 - (Recall #: Z-0718-2024)

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 Fibers, Model No. TFL-FBX200BS

Product Classification:

Class II

Date Initiated: December 4, 2023

Date Posted: January 24, 2024

Recall Number: Z-0718-2024

Event ID: 93629

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).

Status: Ongoing

Product Quantity: 179 units

Code Information:

UDI-DI 00821925043985 Lot KR262848

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated