Olympus Corporation Recalls Disposable Triple Lumen Sphincterotomes Over Performance Concerns

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that some devices did not undergo a necessary thermoforming process during manufacturing. As a result, these instruments may deform and lose performance while in use.

Which Products Are Affected

The recall affects the Disposable Triple Lumen Sphincterotome, specifically Model/Catalog Number KD-431Q-0720. These instruments are designed for use with Olympus endoscopes and guidewires for papillotomy procedures using high-frequency current.

Affected units include all lots with a valid expiration date associated with the following Material REFs and UDI-DIs:

• Material REF (1) 5859230: UDI-DI 04953170042362
• Material REF (2) N6221831: UDI-DI 04953170463778
• Material REF (3) N6221840: UDI-DI 04953170466564

A total of 7,689 units are impacted, including 7,501 units distributed across the United States and 188 units distributed internationally. Distribution in the U.S. includes AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY.

What You Should Do

Olympus notified customers of the issue via a formal letter initiated on January 7, 2026. Healthcare providers and facilities possessing these devices should check their inventory for the affected model and material reference numbers. Affected units should be sequestered and removed from service. For information regarding returns or replacements, contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.

Why This Matters

The failure of these devices to perform as intended during a papillotomy could lead to procedural complications or loss of performance, as these instruments are critical for high-frequency current applications during endoscopic surgery.

Source

Information provided by the FDA under Recall Number Z-1270-2026.