| Date Initiated by Firm | December 18, 2025 |
|---|
| Date Posted | February 13, 2026 |
|---|
| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1362-2026 |
|---|
| Recall Event ID |
98202 |
| 510(K)Number | K243568 |
|---|
| Product Classification |
Unit, electrosurgical, endoscopic (with or without accessories) - Product Code KNS
|
| Product | 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. |
|---|
| Code Information |
RPN: TESLA-B2535-260
Model Number: G60784
UDI-DI code: 00827002607842
Work Order Number / RPN
W4954835 / TESLA-B2535-260
W4954836 / TESLA-B2535-260
W4957208 / TESLA-B2535-260
W4958992 / TESLA-B2535-260
W4960895 / TESLA-B2535-260
W4960896 / TESLA-B2535-260
W4961670 / TESLA-B2535-260
W4965708 / TESLA-B2535-260
W4966040 / TESLA-B2535-260
W4966803 / TESLA-B2535-260
W4967866 / TESLA-B2535-260
W4968515 / TESLA-B2535-260
W4968867 / TESLA-B2535-260
W4969292 / TESLA-B2535-260
W4969674 / TESLA-B2535-260
W4969687 / TESLA-B2535-260
W4970315 / TESLA-B2535-260
W4970662 / TESLA-B2535-260
W4971561 / TESLA-B2535-260
W4972693 / TESLA-B2535-260
W4973085 / TESLA-B2535-260
W4974435 / TESLA-B2535-260
W4974588 / TESLA-B2535-260
W4975407 / TESLA-B2535-260
W4975688 / TESLA-B2535-260
W4977514 / TESLA-B2535-260
W4977824 / TESLA-B2535-260
W4979182 / TESLA-B2535-260
W4979183 / TESLA-B2535-260
W4979665 / TESLA-B2535-260
W4982425 / TESLA-B2535-260
W4982436 / TESLA-B2535-260
REF: TESLA-B2535-450
Model Number: G60785
UDI-DI code: 00827002607859
Work Order Number / RPN:
W4962311 / TESLA-B2535-450
W4966039 / TESLA-B2535-450
W4968222 / TESLA-B2535-450
W4969306 / TESLA-B2535-450
W4970322 / TESLA-B2535-450
W4971499 / TESLA-B2535-450
W4975687 / TESLA-B2535-450
W4977254 / TESLA-B2535-450
W4982013 / TESLA-B2535-450
|
| FEI Number |
1037905
|
Recalling Firm/
Manufacturer |
Wilson-Cook Medical Inc.
4900 Bethania Station Rd
Winston Salem NC 27105-1203
|
| For Additional Information Contact | Cook Medical
800-457-4500 |
|---|
Manufacturer Reason
for Recall | 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 Determined
Cause 2 | 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 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 (FieldActionsNA@CookMedical.com).
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: CustomerRelationsNA@CookMedical.com.
For questions, contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235 |
|---|
| Quantity in Commerce | 153 |
|---|
| Distribution | U.S. Distribution to states of: CA, CO, IN, and NC.
|
|---|
| Total Product Life Cycle | TPLC Device Report |
|---|
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
|
| 510(K) Database | 510(K)s with Product Code = KNS
|
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