HIGH

Wilson-Cook Medical Recalls Bipolar Sphincterotomes Due to Hazard

Wilson-Cook Medical recalled 153 units of its Bipolar Sphincterotomes on December 18, 2025. A void in the device's material may cause an inappropriate electrical current during use. The recall affects specific models distributed in California, Colorado, Indiana, and North Carolina.

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

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

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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.

The Hazard

The recall addresses a potential void in the material between the wire guide and cutting wire lumens. This defect may lead to an inappropriate path of electrical current during cutting, posing a high hazard to patients.

What to Do

Patients and healthcare providers should stop using the device immediately. Follow the instructions provided by Wilson-Cook Medical Inc. for returning the product.

Contact Information

For further details, contact Wilson-Cook Medical Inc. or your healthcare provider. Visit the official recall page at the FDA website for more instructions.

Key Facts

  • 153 units recalled
  • Models G60784 and G60785 affected
  • Distributed in CA, CO, IN, NC
  • Potential electrical hazard
  • Immediate stop-use required

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
ELECTRICAL

Product Details

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
Affected States
CA, CO, NC
Report Date
February 25, 2026
Recall Status
ACTIVE

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