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-431Q-0720 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-431Q-0720; Material REF: (1) 5859230, (2) N6221831, (3) N6221840; UDI-DI: (1) 04953170042362, (2) 04953170463778, (3) 04953170466564; All Lots with a valid expiration date
View official government recall

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