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# Pentax Recalls Duodenoscopes to Replace Parts
- URL: https://www.fdaweb.com/pentax-recalls-duodenoscopes-to-replace-parts/
- Published: 2018-02-07T12:00:00.000Z
- Updated: 2026-09-14T23:20:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140706

FDA says Pentax has recalled all of its ED-3490TK duodenoscopes to replace the forceps elevator, O-ring seal, and distal end and cap, and to update the operation manual to recommend annual maintenance. An agency [post](https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm595603.htm?ref=fdaweb.com) says the design changes are intended to reduce the potential for leakage of patient fluids into the closed elevator channel and under the distal cap.

The post refers to an agency 2/2015 safety communication stating that the complex design of duodenoscopes may impede effective reprocessing. FDA has been working with manufacturers, it says, as they modify and validate their reprocessing instructions to further enhance the safety margin of their devices and show with a high degree of assurance that their reprocessing instructions, when followed correctly, effectively clean and disinfect the duodenoscopes.