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Official recall record

EVIS EXERA III Duodenovideoscope (ref 77487)

Health Canada — Medical Devices · 2025-05-22 · CanadaType II
Issuing authority
Health Canada — Medical Devices
Published
2025-05-22
Country of alert
Canada
Alert level
Type II
Alert type
recall

What the authority reported

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

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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