Wilson-Cook recalls Teslatome Bipolar Sphincterotomes with possible material voids that could cause improper current paths during surgery. Affected models include G60784 and G60785. Contact for details.
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.
Wilson-Cook is recalling certain Teslatome Bipolar Sphincterotomes due to a potential material void that might cause improper electrical current paths during surgical procedures. This could lead to unintended tissue damage if the device is used incorrectly.
The device may have a void in the material separating the wire guide and cutting wire lumens. This void could allow electrical current to travel through an unintended path during cutting, potentially causing tissue damage or injury.
Healthcare professionals who use these devices for sphincterotomy procedures during ERCP (endoscopic retrograde cholangiopancreatography) are most at risk. Patients undergoing these procedures with the recalled devices could be affected.
Check for model numbers G60784 or G60785 on the device. The UDI-DI code starts with 00827002607842 or 00827002607859. These devices were sold with specific work order numbers listed in the recall notice.
Look for model numbers G60784 or G60785 on the device to confirm if it is affected.
The devices may contain a void in the material that separates the wire guide and cutting wire lumens, which could cause an inappropriate path of current during cutting.
Check for model numbers G60784 or G60785 and UDI-DI codes starting with 00827002607842 or 00827002607859. The recall includes specific work order numbers listed in the notice.
The recall notice does not specify a remedy, so contact Wilson-Cook Medical Inc. for further instructions.
We’ve drafted a message you can send Wilson-Cook to request your refund or repair — edit it as you like.
Subject: Recall Z-1362-2026 — Wilson-Cook Wilson-Cook Hello, I own a Wilson-Cook that is covered by recall Z-1362-2026 from Wilson-Cook. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.