Olympus Recalls Sphincterotome Due to Deformation Risk
Olympus Corporation of the Americas recalled 10,257 Single Use 3-Lumen Sphincterotome V devices on January 7, 2026. The recall follows reports that some devices did not undergo thermoforming, risking deformation and loss of performance during medical procedures. This recall affects both domestic and international distribution, including 274 units in the U.S.