Olympus Corporation Recalls Single Use 3-Lumen Sphincterotome V Due to Potential Performance Loss

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Single Use 3-Lumen Sphincterotome V. The recall was prompted by the discovery that some devices did not undergo a necessary thermoforming process during manufacturing. As a result, these instruments could deform and lose performance during medical procedures.

Which Products Are Affected

The recall affects the Single Use 3-Lumen Sphincterotome V, designed for use with Olympus endoscopes and guidewires for papillotomy using high-frequency current.

• Model/Catalog Number: KD-V411M-0330
• Material REF Numbers: N1089530, N1089510, N5411230
• UDI-DI: 04953170380563
• Affected Lots: All lots with a valid expiration date
• Quantity: 33,433 units (36 in the United States; 33,397 distributed internationally)
• Geographic Scope: Distributed nationwide in the U.S. across 45 states and the District of Columbia, as well as international markets.

What You Should Do

Olympus Corporation of the Americas notified affected customers via a formal letter initiated on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model and material reference numbers. For further information regarding returns or replacements, facilities may contact Olympus Corporation of the Americas at their headquarters located at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

Because these instruments are used in surgical procedures involving high-frequency current, a loss of performance or physical deformation of the device during use could compromise the safety and efficacy of the medical procedure.

Source

Information provided by the FDA under recall number Z-1271-2026.