Teslatome recallZ-1362-2026 · Wilson-Cook Medical Inc. · initiated Dec 18, 2025

Why it was recalled

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.

FDA root cause category: Under Investigation by firm

What the company is doing

On 12/18/2025, the firm priority mailed an "URGENT: MEDICAL DEVICE RECALL" Letter to customers informing them that the firm is removing Teslatome Bipolar Sphincterotomes from the market because they are nonconforming. Customers are instructed to: 1. Examine inventory immediately to determine if you have affected devices. Immediately cease use of the affected devices and quarantine all affected devices. 2. Return the affected devices to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a credit. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter. Even if you do not have affected devices on hand, you must still complete the Acknowledgement and Receipt Form and return via fax (812.339.7316) or email ([email protected]). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: [email protected]. For questions, contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235

Recall details

Recall number

Z-1362-2026

Status

Open, Classified

Initiated by the company

Dec 18, 2025

Posted by the FDA

Feb 13, 2026

Recalling firm

Wilson-Cook Medical Inc.

Quantity

153

Product code

KNS

FDA submissions

K243568

Distribution

U.S. Distribution to states of: CA, CO, IN, and NC.

Product description

Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2535-450 Model Number: G60785 UDI-DI code: 00827002607859 These devices are used for cannulation of the ductal system and for sphincterotomy. If preloaded, the device also aids in bridging difficult strictures during ERCP. It is indicated for sphincterotome-aided, wire-guided selective cannulation of the biliary ducts.

Devices named in this recall

2 devices in the FDA device registry whose identifier appears in the recall's code information.

• Teslatome G60784

  Cook Incorporated · Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall2 reports
• Teslatome G60785

  Cook Incorporated · Unit, electrosurgical, endoscopic (with or without accessories)
  1 recall0 reports

Product lines

• TeslatomeCook Incorporated · 2 models · 2 reports · 1 recall