PlainRecalls
FDA Devices Moderate Class II Ongoing

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Reported: February 22, 2023 Initiated: December 21, 2022 #Z-1132-2023

Product Description

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL

Reason for Recall

A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination

Details

Units Affected
1 unit
Distribution
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Location
Center Valley, PA

Frequently Asked Questions

What product was recalled?
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon, colon, and ileocecal valve) Model/Serial: CF-Q180AL. Recalled by Olympus Corporation of the Americas. Units affected: 1 unit.
Why was this product recalled?
A single CF-Q180AL colonovideoscope was utilized in a veterinary endoscopy procedure in advance of being assigned to a medical facility as a service loaner in error, potential for microbial contamination
Which agency issued this recall?
This recall was issued by the FDA Devices on February 22, 2023. Severity: Moderate. Recall number: Z-1132-2023.