Health Canada — Medical Devices · Canada · 2025-05-22 · Type II
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Reported risk: 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
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