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

What Happened

Olympus Corporation of the Americas has initiated a voluntary Class II recall of its Single Use 3-Lumen Sphincterotome V. The recall was prompted by the discovery that certain devices did not undergo a required thermoforming process. As a result, these instruments could deform, leading to a loss of performance during medical procedures.

Which Products Are Affected

The recall affects a total of 30,489 units, including 11,779 units distributed in the United States and 18,710 units distributed internationally.

• Product Name: Single Use 3-Lumen Sphincterotome V
• Model/Catalog Number: KD-V431M-0720
• Material REFs: (1) N1090410, (2) N1090430, (3) N5411930
• UDI-DI: 04953170184178
• Recall Number: Z-1275-2026
• 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 facilities and distributors should check their inventory for the affected model and catalog numbers listed above. Users should follow the specific instructions provided in the firm’s notification letter regarding the handling and return of affected products.

Why This Matters

These instruments are designed for use with endoscopes and guidewires for papillotomy using high-frequency current. If the device deforms due to the lack of thermoforming, it may fail to perform as intended during these sensitive medical procedures, potentially impacting patient safety.

Source

Information provided by the FDA.