Wilson-Cook Medical Inc. recalls Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B253…

Recall date

December 18, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1362-2026

FDA classification

Class II

Brand / firm

Wilson-Cook Medical Inc.

Sold / distributed

U.S. Distribution to states of: CA, CO, IN, and NC.

Why it was recalled

Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens, which may cause an inappropriate path of current during cutting.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.