Olympus Recalls VISERA™ Imaging System Valves Due to Rubber Fragment Detachment Risk

What Happened

Olympus Medical Systems Corp. has initiated a recall investigation following an increase in complaints regarding rubber fragment detachment. The issue involves fragments breaking off from the slits of MAJ-210 and MAJ-1218 valves used within the VISERA™ Imaging System.

Which Products Are Affected

The recall affects all lots of the following components manufactured by Olympus Medical Systems Corp.:

• VISERA™ Imaging System - Valve: Model or catalogue number MAJ-1218 (All lots)
• Biopsy Valve: Model or catalogue number MAJ-210 (All lots)

The manufacturer, Olympus Medical Systems Corp., is located in Tokyo, Japan.

What You Should Do

Olympus is highlighting the critical importance of strictly adhering to the provided Instructions for Use (IFU) for these devices. The company is currently investigating the cause of the fragment detachment and has announced that an updated customer notification will be shared with users by mid-2026.

Why This Matters

The detachment of rubber fragments during the use of imaging and biopsy valves poses a potential risk of foreign material entering a patient or compromising the integrity of medical procedures.

Source

Information provided by Health Canada.