FDA recall Z-2497-2021

Olympus Corporation of the Americas · Class II · device

Product

EVIS EXERA BF-XT160 Bronchofibervideoscope, Model No. BF-XT160

Reason for recall

A gluing step was not performed during the manufacturing of the affected device's insertion tube. There is a potential for the insertion tube to develop a leak, which poses an infection control risk.

Distribution

US Nationwide distribution in the states of CA, IL, MA, MD, MI, NY, OH, OR, and PA.

Key facts

Status: Terminated
Initiation date: 2021-08-17
Report date: 2021-09-29
Termination date: 2024-01-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2497-2021