FDA recall Z-0718-2024

Olympus Corporation of the Americas · Class II · device

Product

SOLTIVE SuperPulsed Laser Fibers, Model No. TFL-FBX200BS

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.

Key facts

Status: Ongoing
Initiation date: 2023-12-04
Report date: 2024-01-24
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0718-2024