CanadaThe VISERA™ Imaging System valves — Biopsy Valve model MAJ-210 and Valve model MAJ-1218 (all lots/serial numbers) — are affected. Olympus is investigating an increase in complaints of rubber fragment detachment in the slit of these models, is stressing strict adherence to the instructions for use, and advises contacting the manufacturer for more information.
What's being recalled
Companies: Olympus Medical Systems Corp., 2951 Ishikawa-Cho, Hachioji-Shi, Tokyo-To, Japan, 192-8507.
How to identify it
Affected products: VISERA™ Imaging System - Valve; Lot or serial number: All lots.; Model or catalogue number: MAJ-1218
Affected products: Biopsy Valve; Lot or serial number: All lots.; Model or catalogue number: MAJ-210
The hazard
Olympus is investigating an increase in complaints associated with rubber fragment detachment in the
slit of MAJ-210 and MAJ-1218. Olympus is highlighting the importance of strictly adhering to the IFU. Olympus will share an updated customer notification by mid-2026.
What to do
Contact the manufacturer if you require additional information.
The official notice
This page is a summary of the notice published by Health Canada, collected from Health Canada, CFIA and Transport Canada. Check the original before you act on it.
Read the official notice (opens in a new tab)