Olympus Recalls Disposable Triple Lumen Sphincterotome Due to Potential Deformation and Performance Loss

What Happened

Olympus Corporation of the Americas has initiated a voluntary recall of its Disposable Triple Lumen Sphincterotome. The recall was prompted by the discovery that certain devices did not undergo a necessary thermoforming process during manufacturing. As a result, these instruments could deform and lose performance during medical procedures.

Which Products Are Affected

The recall involves the following medical device:

• Brand Name: Disposable Triple Lumen Sphincterotome
• Model/Catalog Number: KD-401Q-0320
• Material REF: 5856630
• UDI-DI: 04953170041587
• Affected Lots: All lots with a valid expiration date
• Quantity: 999 units

These instruments are designed for use with an Olympus endoscope and guidewire for papillotomy using high-frequency current. The distribution of these products is worldwide, including nationwide distribution across the United States in 44 states, the District of Columbia, and Guam.

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 number (KD-401Q-0320). If affected units are found, users should follow the specific instructions provided in the firm’s notification letter regarding the handling and return of the devices. For further information, facilities may contact Olympus Corporation of the Americas at their Center Valley, PA headquarters.

Why This Matters

This recall is classified as a Class II event by the FDA. Because these devices are used in surgical procedures involving high-frequency current, any deformation or loss of performance could lead to complications during the papillotomy, potentially impacting patient safety and procedural success.

Source

This information is based on official recall data provided by the FDA under recall number Z-1293-2026.