Olympus Recalls Single Use Biopsy Valves Due to Potential Rubber Fragment Detachment

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Single use Biopsy Valve, Model MAJ-210. The recall was triggered by the discovery of a potential defect where rubber fragments may detach from the valve during clinical use. This device is designed to be attached to the instrument channel port of compatible endoscopes to prevent the reflux of body fluids.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Olympus Single use Biopsy Valve
• Model/Catalog Number: MAJ-210
• UDI-DI: 14953170152433, 14953170452069
• Lot Numbers: All lot numbers are included in this recall.
• Quantity: 95,882 boxes (each containing 20 units).
• Recall Number: Z-1488-2026

What You Should Do

Olympus initiated the recall process on January 29, 2026, via a notification letter to customers. Healthcare facilities and distributors should immediately check their inventory for Model MAJ-210 biopsy valves. Affected units should be quarantined and handled according to the instructions provided in the firm’s notification letter. For further information or assistance regarding this recall, contact Olympus Corporation of the Americas at their headquarters in Center Valley, PA.

Why This Matters

The detachment of rubber fragments during an endoscopic procedure poses a significant safety risk, as foreign material could potentially enter a patient’s body or interfere with the proper functioning of medical instruments.

Source

Information provided by the FDA under Recall Event ID 98240.