Olympus Recalls Single Use Sphincterotome V Due to Potential Performance Failure

What Happened

Olympus Corporation of the Americas has initiated a voluntary Class II recall of its Single Use Sphincterotome V (Distal Wire guided). The recall was issued because certain devices did not undergo a necessary thermoforming process. As a result, these instruments could deform and lose performance during use, potentially impacting medical procedures.

Which Products Are Affected

The recall involves the Single Use Sphincterotome V (Distal Wire guided), specifically Model/Catalog Number KD-VC431Q-0720.

Details for identification include:

• Material REFs: N5391530, N5391510, N5777830
• UDI-DI: 04953170466427
• Quantity: 12,641 units (8,789 in the U.S.; 3,852 internationally)
• Affected Lots: All lots with a valid expiration date

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 initiated the recall notification via letter 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 to prevent use. For further instructions regarding the return or replacement of these devices, contact Olympus Corporation of the Americas at their headquarters in Center Valley, PA.

Why This Matters

These instruments are designed for use with Olympus endoscopes and guidewires 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 (Recall Number: Z-1269-2026).