FDAClass IIFebruary 22, 2023

EVIS EXERA III Colonovideoscope-For endoscopy and recall: Contamination

EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon…

Why was EVIS EXERA III Colonovideoscope-For endoscopy and 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

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI: 04953170202315 Serial number 2807443

Product
EVIS EXERA III Colonovideoscope-For endoscopy and endoscopic surgery within the lower digestive tract (including the anus, rectum, sigmoid colon…
Recalling firm
Olympus Corporation of the Americas
Quantity
1 unit
Distribution
US Nationwide distribution in the states of CA, FL, GA, NY, OR, VA.
Recall date
February 22, 2023
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls