Quick Facts at a Glance
- Recall Date
- December 18, 2025
- Hazard Level
- HIGH
- Brand
- Wilson-Cook Medical
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- Geographic Scope
- 3 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Wilson-Cook Medical
- Product type
- Bipolar Sphincterotomes
- Model numbers
- RPN: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 Work Order Number / RPN W4954835 / TESLA-B2535-260 W4954836 / TESLA-B2535-260 W4957208 / TESLA-B2535-260 W4958992 / TESLA-B2535-260 W4960895 / TESLA-B2535-260 W4960896 / TESLA-B2535-260 W4961670 / TESLA-B2535-260 W4965708 / TESLA-B2535-260 W4966040 / TESLA-B2535-260 W4966803 / TESLA-B2535-260 W4967866 / TESLA-B2535-260 W4968515 / TESLA-B2535-260 W4968867 / TESLA-B2535-260 W4969292 / TESLA-B2535-260 W4969674 / TESLA-B2535-260 W4969687 / TESLA-B2535-260 W4970315 / TESLA-B2535-260 W4970662 / TESLA-B2535-260 W4971561 / TESLA-B2535-260 W4972693 / TESLA-B2535-260 W4973085 / TESLA-B2535-260 W4974435 / TESLA-B2535-260 W4974588 / TESLA-B2535-260 W4975407 / TESLA-B2535-260 W4975688 / TESLA-B2535-260 W4977514 / TESLA-B2535-260 W4977824 / TESLA-B2535-260 W4979182 / TESLA-B2535-260 W4979183 / TESLA-B2535-260 W4979665 / TESLA-B2535-260 W4982425 / TESLA-B2535-260 W4982436 / TESLA-B2535-260 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 Work Order Number / RPN: W4962311 / TESLA-B2535-450 W4966039 / TESLA-B2535-450 W4968222 / TESLA-B2535-450 W4969306 / TESLA-B2535-450 W4970322 / TESLA-B2535-450 W4971499 / TESLA-B2535-450 W4975687 / TESLA-B2535-450 W4977254 / TESLA-B2535-450 W4982013 / TESLA-B2535-450
- Sold at
- Multiple Retailers
- Where affected
- CA, CO, NC
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 18, 2025
Reported by FDA DEVICE
February 25, 2026
RecallRadar source check
March 4, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
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.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Wilson-Cook Medical Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
Bipolar Sphincterotomes are medical devices used during endoscopic procedures for cannulation of the biliary ducts. They are crucial for performing sphincterotomies, which help in the treatment of various biliary conditions.
Why This Is Dangerous
The defect may create a void between the wire guide and cutting wire lumens, causing an improper electrical current path during use. This could lead to unintended cuts or burns during the procedure.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall necessitates immediate cessation of use, creating potential delays in medical treatments for affected patients.
Practical Guidance
How to identify if yours is affected
- Verify the REF number and model number on the device packaging or label.
- Check the UDI-DI codes against the recall notice.
- Consult with your healthcare provider if unsure.
Where to find product info
The REF number and model number can typically be found on the product packaging or on the device itself near the handle or control panel.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds after the manufacturer receives the returned devices.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Reach out to your healthcare provider for assistance.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- Always check for recall notices before using medical devices.
- Ensure devices are from reputable manufacturers with good safety records.
- Ask healthcare providers about any device-specific risks before procedures.
Documentation advice
Keep records of your purchase, any correspondence regarding the recall, and photos of the device for your records.
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Product Details
The recalled products include Teslatome Bipolar Sphincterotomes with REF numbers TESLA-B2535-260 (Model G60784) and TESLA-B2535-450 (Model G60785). Each unit has a UDI-DI code, 00827002607842 and 00827002607859 respectively. The devices were distributed in California, Colorado, Indiana, and North Carolina.
Key Facts
- Models G60784 and G60785 affected
- Distributed in CA, CO, IN, NC
- Potential electrical hazard
- Immediate stop-use required
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Safety Guide
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