Olympus 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 the Single Use 3-Lumen Sphincterotome V. The recall was prompted by a manufacturing issue where certain devices did not undergo a required thermoforming process. According to the FDA, these affected instruments could potentially deform and lose performance during use.

Which Products Are Affected

The recall affects 3,954 units distributed worldwide, including nationwide across the United States. Affected states and territories include 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.

Product Details:

• Product Name: Single Use 3-Lumen Sphincterotome V
• Model/Catalog Number: KD-V411M-1520
• Material REF: (1) N5411630, (2) N1089910
• UDI-DI: (1) 04953170380600
• Affected Lots: All lots with a valid expiration date
• Recall Number: Z-1290-2026

What You Should Do

Olympus initiated the recall process by sending notification letters to affected customers on January 7, 2026. Healthcare providers and facilities should check their inventory for the specified model and material reference numbers. Any affected units should be handled according to the instructions provided in the firm’s notification letter. For further information, consumers may contact Olympus Corporation of the Americas at their headquarters in Center Valley, Pennsylvania.

Why This Matters

These instruments are designed for use with endoscopes and guidewires during papillotomy procedures using high-frequency current. A device that deforms or loses performance during such a procedure could lead to surgical complications or the need for additional medical intervention.

Source

Information provided by the FDA.