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

What Happened

Olympus Corporation of the Americas has voluntarily initiated a recall of its Single Use Biopsy Valves. The recall was issued following the identification of a potential for rubber fragments to detach from the valve during use. These devices are designed to be attached to the instrument channel port of compatible endoscopes to prevent the leakage of body fluids during medical procedures.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Olympus Single Use Biopsy Valve
• Model/Catalog Number: MAJ-1218
• UDI-DI: 14953170154291
• Lot Information: All Lot Numbers are included in this recall
• Quantity: 1,276 boxes (20 units per box)
• Recall Number: Z-1489-2026

The affected products were distributed nationwide across the United States.

What You Should Do

Olympus Corporation of the Americas initiated the recall process on January 29, 2026, by sending notification letters to affected customers. Healthcare facilities and providers should immediately check their inventory for Model MAJ-1218 biopsy valves. If affected products are found, users should follow the specific instructions provided in the firm’s notification letter regarding the return or management of the devices.

Why This Matters

The detachment of rubber fragments during a procedure poses a risk to patient safety, as foreign material could potentially be introduced into the patient’s body or interfere with the proper functioning of the endoscopic equipment.

Source

Information provided by the U.S. Food and Drug Administration (FDA).