FDA recall Z-2467-2023
Olympus Corporation of the Americas · Class II · device
Product
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Reason for recall
Recent reports of patient infection.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-07-27
- Report date
- 2023-09-06
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2467-2023