Olympus Corporation of the Americas recalled 5,946 single use sphincterotomes on January 7, 2026. The devices may deform and lose performance due to improper thermoforming. Healthcare providers and patients must cease use immediately to avoid potential hazards.
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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Model/Catalog Number: KD-VC411Q-0320. Distributed worldwide including all U.S. states. Quantity recalled: 5,946 units.
The sphincterotome may deform if it did not undergo proper thermoforming. This deformation can lead to loss of performance during medical procedures.
No specific incidents or injuries have been reported related to this recall. However, the risk of device failure poses a significant hazard.
Stop using the device immediately. Follow the manufacturer’s recall instructions and contact Olympus Corporation of the Americas for further guidance.
For more information, visit the FDA recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-1280-2026.
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