FDA recall Z-2572-2021

Olympus Corporation of the Americas · Class II · device

Product

BF-1T180 EVIS EXERA II Bronchovideoscope, Model No. BF-1T180

Reason for recall

The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

Distribution

Domestic distribution nationwide. Product also distributed globally.

Key facts

Status: Terminated
Initiation date: 2021-08-16
Report date: 2021-10-06
Termination date: 2024-03-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Center Valley, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2572-2021