Olympus Recalls Single Use 3-Lumen Sphincterotome V Due to Device Deformation Risk

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of the Single Use 3-Lumen Sphincterotome V. The recall was triggered because certain devices did not undergo a necessary thermoforming process during manufacturing. This defect can cause the instruments to deform and lose performance during use.

Which Products Are Affected

The recall involves the following specific medical device:

• Product Name: Single Use 3-Lumen Sphincterotome V
• Model/Catalog Number: KD-V411M-3025
• Material REF: N1090210
• Code Information: All lots with a valid expiration date
• Quantity: 1,025 units (OUS only)

Distribution was worldwide, including nationwide in the United States across 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 began notifying customers of the issue via a letter sent on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model and material reference numbers. Any affected units should be handled according to the instructions provided in the firm’s notification letter. For further assistance, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034.

Why This Matters

These instruments are used in specialized endoscopic procedures (papillotomy) involving high-frequency current. If a device deforms or fails to perform as intended during a procedure, it could lead to surgical complications or the need for additional medical intervention.

Source

This recall is documented by the FDA under recall number Z-1296-2026.