Wilson-Cook Medical Inc. Recalls Teslatome Bipolar Sphincterotomes Due to Electrical Hazard

What Happened

Wilson-Cook Medical Inc. has initiated a voluntary recall of certain Teslatome Bipolar Sphincterotomes. The recall was prompted by the discovery that the devices may contain a void in the material that separates the wire guide and cutting wire lumens. This defect could cause an inappropriate path of electrical current during the cutting phase of a medical procedure.

Which Products Are Affected

The recall affects 153 units distributed to California, Colorado, Indiana, and North Carolina. The specific products include:

• Product Name: Teslatome Bipolar Sphincterotomes
• REF: TESLA-B2535-260 | Model Number: G60784 | UDI-DI: 00827002607842
• REF: TESLA-B2535-450 | Model Number: G60785 | UDI-DI: 00827002607859

Affected Work Order Numbers for TESLA-B2535-260 include: W4954835, W4954836, W4957208, W4958992, W4960895, W4960896, W4961670, W4965708, W4966040, W4966803, W4967866, W4968515, W4968867, W4969292, W4969674, W4969687, W4970315, W4970662, W4971561, W4972693, W4973085, W4974435, W4974588, W4975407, W4975688, W4977514, W4977824, W4979182, W4979183, W4979665, W4982425, and W4982436.

Affected Work Order Numbers for TESLA-B2535-450 include: W4962311, W4966039, W4968222, W4969306, W4970322, W4971499, W4975687, W4977254, and W4982013.

What You Should Do

Wilson-Cook Medical Inc. notified affected customers via a formal letter initiated on December 18, 2025. Healthcare facilities and distributors in the affected states (CA, CO, IN, NC) should identify and sequester any remaining stock of the listed model and work order numbers. Follow the specific instructions provided in the firm’s notification letter regarding the return or disposal of the devices.

Why This Matters

These devices are used for critical medical procedures, including cannulation of the ductal system and sphincterotomy. An unintended path of electrical current during surgery poses a significant risk of internal injury or burns to the patient.

Source

FDA Recall Event 98202 - Recall Number: Z-1362-2026