Olympus Recalls Single Use 3-Lumen Sphincterotome V Due to Potential Device Deformation

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 the discovery that certain devices did not undergo a required thermoforming process. According to the FDA, these affected instruments could potentially deform, leading to a loss of performance during medical procedures.

Which Products Are Affected

The recall affects a total of 136,037 units, including 9,959 units distributed in the United States and 126,078 units distributed internationally.

• Product Name: Single Use 3-Lumen Sphincterotome V
• Model/Catalog Number: KD-V411M-0725
• Material REF: (1) N1089710, (2) N5411430
• UDI-DI: 04953170380587
• Affected Lots: All lots with a valid expiration date
• Recall Number: Z-1273-2026

The product was distributed nationwide across the United States, 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, as well as internationally.

What You Should Do

Olympus initiated the recall by sending notification letters to affected customers. Healthcare facilities and providers should immediately check their inventory for the specified model and material reference numbers. If you possess affected units, follow the instructions provided in the firm’s notification letter regarding the handling or return of the devices.

Why This Matters

These instruments are designed for use with Olympus endoscopes and guidewires for papillotomy using high-frequency current. A loss of performance or device deformation during such a procedure could impact the safety and efficacy of the medical intervention.

Source

Information provided by the FDA.