medical Class II Updated 2026-02-11

Olympus Corporation of the Americas recalls Product Name: Single Use 3-Lumen Sphincterotome V Model/Cat

Recalled Product

Product Name: Single Use 3-Lumen Sphincterotome V Model/Catalog Number: KD-V411M-0725; 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-0725; Material REF: (1) N1089710, (2) N5411430; UDI-DI: (1) 04953170380587, (2) 04953170380587; All Lots with a valid expiration date
View official government recall

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