Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-411q-0720 Product Description: These Instruments Have Been Designed To Be Used With An Olympus Endoscope And Guidewire For
Recall Summary Olympus is recalling Disposable Triple Lumen Sphincterotome devices, model KD-411Q-0720, used with endoscopes during medical procedures. Some devices may not have undergone proper manufacturing and could deform or stop working correctly during use. This is a Class II recall affecting the medical devices distributed by Olympus Corporation of the Americas.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-411Q-0720 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/814f503b-5b8a-4ea3-a961-d5c47a870f80