Recall Z-1362-2026 ยท KNS Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Wilson-Cook Medical Inc.
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 selec
| Date | Feb 13, 2026 (initiated Dec 18, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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 busines |
| Quantity | 153 |
| Distribution | U.S. Distribution to states of: CA, CO, IN, and NC. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K243568 | Teslatome Bipolar Sphincterotome; Tesla BiCord Active Cord Wilson-Cook Medical, Inc., Jan 17, 2025 |