Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-401q-0320 Product Description: These Instruments Have Been Designed To
Recall Summary Olympus Corporation of the Americas is recalling Disposable Triple Lumen Sphincterotome devices (Model KD-401Q-0320) used during endoscopy procedures. Some devices may not have been properly manufactured and could deform during use, causing them to lose their intended function. The recall affects medical facilities that received these instruments for use with Olympus endoscopes.
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Brand Name: Disposable Triple Lumen Sphincterotome Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0320 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/9e53044f-1ac8-4fec-8a20-f69139a485dd