Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: Recalled by Wilson-Cook Medical Inc. Due to Due to product that may contain a void...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Wilson-Cook Medical Inc. directly.
Affected Products
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.
Quantity: 153
Why Was This 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.
Where Was This Sold?
This product was distributed to 4 states: CA, CO, IN, NC
About Wilson-Cook Medical Inc.
Wilson-Cook Medical Inc. has 22 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report