Olympus Recalls Disposable Triple Lumen Sphincterotome Due to Potential Device Deformation

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was triggered after it was discovered that certain devices did not undergo a necessary thermoforming process. According to the FDA, these instruments could potentially deform, which may lead to a loss of performance during medical procedures.

Which Products Are Affected

The recall affects the following medical device:

• Product Name: Disposable Triple Lumen Sphincterotome
• Model/Catalog Number: KD-411Q-0730
• Recall Number: Z-1286-2026
• Material REFs: 5858230, N6221731, N6221740
• UDI-DI: 04953170466557
• Quantity: 887 units total (650 in the U.S.; 237 internationally)
• Scope: All lots with a valid expiration date are included.

Distribution in the United States includes the following states and territories: 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 facilities and providers should check their inventory for Model KD-411Q-0730 and follow the instructions provided in the firm’s notification letter. For additional information or questions regarding the return of affected units, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

These instruments are designed for use with endoscopes and guidewires for papillotomy using high-frequency current. If the device deforms during a procedure, it could fail to perform as intended, potentially complicating the surgical intervention.

Source

Information provided by the FDA under Recall Event ID 98252.