Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-401q-0330 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For
Recall Summary Olympus Corporation of the Americas is recalling Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0330) used during endoscopic procedures because some units may not have been properly heat-formed during manufacturing, which could cause them to deform and not work as intended. These devices are used with Olympus endoscopes to perform papillotomy procedures. This is a Class II recall affecting medical facilities that use these instruments.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
- Reason
- Devices which did not undergo thermoforming could deform and lose performance.
- Classification
- Class II
- Category
- consumer product recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-01-07
- Status
- Open, Classified
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/7297f447-dbe8-4bb7-9707-7a5701fd38ab