Olympus Corporation recalled 4,183 units of the Single Use 3-Lumen Sphincterotome V on January 7, 2026. Devices may deform and lose performance due to inadequate thermoforming. Healthcare providers should immediately stop using the affected products and follow recall instructions.
Devices which did not undergo thermoforming could deform and lose performance.
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions. Notification method: Letter
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The affected product is the Single Use 3-Lumen Sphincterotome V, Model/Catalog Number KD-VC431Q-0730. It was distributed worldwide, including 821 units in the U.S. and 3,362 units internationally.
The recalled devices did not undergo necessary thermoforming processes, which may cause them to deform. Deformation can result in loss of performance during procedures, posing a serious risk to patient safety.
There have been no reported injuries or incidents related to this recall at this time. The potential for injury remains high due to the nature of the device.
Stop using the device immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions regarding the recall.
For more details, contact Olympus Corporation of the Americas. Further information can be found at the FDA website: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1277-2026.
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