Product Wiki · Recalls · Health Canada — Medical Devices

Evis Exera III Duodenovideoscope — recall 74400

Health Canada — Medical Devices · Canada · 2023-10-10 · Type I

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Agency
Health Canada — Medical Devices
Recall identifier
74400
Date of alert
2023-10-10
Country / jurisdiction
Canada
Risk level
Type I
Risk type
recall
Product category
Gastroenterology and urology
Product type
Medical devices
Reported risk: Olympus is initiating this action after becoming aware of recent reports of infections and positive cultures and inquiries from the FDA regarding these reports. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus service, and informing users about an updated manual intended to improve comprehension of existing steps. Olympus is reminding users that the use of a damaged or contaminated endoscope can present an infection risk to patients. Recall start date: le 22 septembre, 2023
Primary source: https://recalls-rappels.canada.ca/en/alert-recall/evis-exera-iii-duodenovideosco

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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