FDA recall, , Moderate risk
Wilson-Cook Teslatome Bipolar Sphincterotomes
Teslatome Bipolar Sphincterotomes may have a void in material separating wire guide and cutting wire lumens, causing inappropriate current path during cutting.
Summary by Recall Canary from the FDA notice
What happened
Wilson-Cook Medical Inc., of Winston Salem, North Carolina, recalled Teslatome Bipolar Sphincterotomes because the product 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.
The devices are used for cannulation of the ductal system and for sphincterotomy, and if preloaded, aid in bridging difficult strictures during ERCP. The recall began December 18, 2025, and the FDA added it to its Enforcement Report on February 13, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
A UDI-DI is the device identifier printed with the barcode on the device label.
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260
- Model
- G60784
Model Number: G60784
- UDI-DI
- 00827002607842
Model Number: G60785
- UDI-DI
- 00827002607859
From the FDA notice
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.
Recall details
- Company began the recall
- Sold in
U.S. Distribution to states of: California, Colorado, Indiana, and North Carolina.
- Company
- Wilson-Cook Medical Inc.Winston Salem, North Carolina
- Hazard
- Device defect
- Risk
Moderate risk
Using it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98202
- Recall number
- Z-1362-2026
All recalls from Wilson-Cook Medical Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
