PlainRecalls
FDA Devices Moderate Class II Ongoing

EVIS EXERA III Gastrointestinal Videoscope

Reported: November 15, 2023 Initiated: October 2, 2023 #Z-0288-2024

Product Description

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.

Details

Units Affected
1687 units
Distribution
Nationwide Distribution.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA III Gastrointestinal Videoscope. Recalled by Olympus Corporation of the Americas. Units affected: 1687 units.
Why was this product recalled?
Sterilization failures when devices are sterilized per the Reprocessing Manual due to lack of drying time for the endoscope channel.
Which agency issued this recall?
This recall was issued by the FDA Devices on November 15, 2023. Severity: Moderate. Recall number: Z-0288-2024.