medical Class II Updated 2026-02-11

Olympus Corporation of the Americas recalls Product Name: Disposable Triple Lumen Sphincterotome Model/

Recalled 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.

Hazard / Issue

Devices which did not undergo thermoforming could deform and lose performance.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/Catalog Number: KD-411Q-0730; Material REFs: (1) 5858230, (2) N6221731, (3) N6221740; UDI-DI: (1)04953170466557, (2)04953170466557, (3)04953170466557; All Lots with a valid expiration date
View official government recall

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