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-3020 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-3020; Material REF: N1090110; UDI-DI: N/A; All Lots with a valid expiration date
View official government recall

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