Olympus Corporation Recalls Disposable Triple Lumen Sphincterotomes Due to Potential Device Deformation

What Happened

Olympus Corporation of the Americas has issued a voluntary, firm-initiated recall for its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that certain devices did not undergo the required thermoforming process. Consequently, these instruments could potentially deform and lose performance during use.

Which Products Are Affected

The recall involves the following medical device:

• Product Name: Disposable Triple Lumen Sphincterotome
• Model/Catalog Number: KD-411Q-0720
• Material REF: 5858030
• Affected Lots: All lots with a valid expiration date
• Quantity: 125 units (7 in the United States, 118 international units)

These instruments are designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The distribution scope includes international locations and U.S. nationwide distribution across 44 states and territories, including 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

The firm began notifying customers via letter on January 7, 2026. Healthcare facilities and providers should immediately check their inventory for Model KD-411Q-0720. Affected units should be sequestered to prevent use. For information regarding the return or replacement of these devices, contact Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034-8229.

Why This Matters

Because these devices are used in surgical procedures involving high-frequency current, any deformation or loss of performance could compromise the precision of the papillotomy and potentially impact patient safety during the procedure.

Source

Information provided by the FDA under Recall Number Z-1285-2026.