Product Name: Disposable Triple Lumen Sphincterotome Model/catalog Number: Kd-411q-0730 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 Sphincterotomes (model KD-411Q-0730), which are medical instruments used with endoscopes to perform certain procedures. Some devices may not have been properly formed during manufacturing, which could cause them to deform and not work as intended. This recall affects the specific model listed above manufactured 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-0730 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/726319ab-a8a0-40de-be97-8e1abec21d8f