medical Class II Updated 2026-02-11

Olympus Corporation of the Americas recalls Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphi

Recalled Product

Brand Name: CleverCut Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0320; Software Version: N/A 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-V411M-0320; Material REF: (1) N1089430, (2) N1089410, (3) N5411130; UDI-DI: (1) 04953170183973, (2) 04953170466274, (3) 04953170380556; All Lots with a valid expiration date

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