Olympus Recalls CleverCut Single Use 3-Lumen Sphincterotome V Over Performance Concerns

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of the CleverCut Single Use 3-Lumen Sphincterotome V. The recall was issued after it was discovered that certain devices did not undergo a necessary thermoforming process. According to the FDA, devices that skipped this step could deform and lose performance during medical procedures.

Which Products Are Affected

The recall involves the following medical device:

• Brand Name: CleverCut
• Product Name: Single Use 3-Lumen Sphincterotome V
• Model/Catalog Number: KD-V411M-0320
• Material REFs: N1089430, N1089410, N5411130
• UDI-DIs: 04953170183973, 04953170466274, 04953170380556
• Quantity: 72,023 units (3,920 in the U.S.; 68,103 internationally)
• Affected Lots: All lots with a valid expiration date

Distribution in the United States 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 initiated the recall notification via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for the affected model and material reference numbers. If affected products are found, users should follow the instructions provided in the firm’s notification letter regarding the handling and return of the devices. For further inquiries, consumers can contact Olympus Corporation of the Americas at their headquarters in Center Valley, PA.

Why This Matters

These instruments are designed for use with endoscopes for papillotomy using high-frequency current. A device that deforms or loses performance during such a procedure could lead to surgical complications or ineffective treatment.

Source

Information provided by the FDA under Recall Number Z-1268-2026.