Wilson-Cook Medical Inc. Recalls Teslatome Bipolar Sphincterotomes Due to Electrical Hazard
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Wilson-Cook Medical Inc. is recalling 153 Teslatome Bipolar Sphincterotomes because a material defect may cause an inappropriate path of electrical current during medical procedures.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on April 6, 2026 and geographically references CA, CO, IN, NC. Its severity classification of "high" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
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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
Original source: FDA Official Notice ↗
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