FDA recall Z-2401-2023

Olympus Corporation of the Americas · Class II · device

Product

UroPass Ureteral Access Sheaths, 5 pieces/box

Reason for recall

Dilator tips may break in the package and in patients during surgical procedures.

Distribution

Worldwide distribution - United States Nationwide and the countries of South Korea, Canada, Australia, Taiwan, Hong Kong, Japan, and Germany.

Key facts

Status
Ongoing
Initiation date
2023-05-19
Report date
2023-08-23
Voluntary/Mandated
Voluntary: Firm initiated
Location
Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2401-2023