FDA recall Z-0288-2024
Olympus Corporation of the Americas · Class II · device
Product
EVIS EXERA III Gastrointestinal Videoscope
Reason for recall
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Distribution
Nationwide Distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2023-10-02
- Report date
- 2023-11-15
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Center Valley, PA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0288-2024