Health product recall

EVIS EXERA III Duodenovideoscope

Last updated

Summary

Product
EVIS EXERA III Duodenovideoscope
Issue
Medical devices - Labelling and packaging
What to do

Contact the manufacturer if you require additional information. 

Audience
Healthcare

Affected products

Affected products

Lot or serial number

Model or catalogue number

EVIS EXERA III Duodenovideoscope

All lots.

TJF-Q190V

Issue

Olympus is conducting this recall following recent post-market surveillance data suggesting a possible association of higher microbial contamination levels from TJF duodenoscopes when manual cleaning was delayed beyond one hour and a presoak was performed, compared to those TJF duodenoscopes where manual cleaning began within one hour after patient procedure. the reprocessing manual for the TJF-Q190V has been updated to remove the presoak step and includes instructions that require manual cleaning to begin within one hour after patient procedure for the TJF duodenoscope.

Recall start date: May 9, 2025

Additional information

Details
Original published date:
Alert / recall type
Health product recall
Category
Health products - Medical devices - Gastroenterology and urology
Companies
Olympus Medical Systems Corp.
2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507
Published by
Health Canada
Audience
Healthcare
Recall class
Type II
Identification number
RA-77487

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