Recall archive / FDA device enforcement
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF: TESLA-B2... — FDA record Z-1362-2026
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Dec 18, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- 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.
- Classification
- Class II
- Recalling firm
- Wilson-Cook Medical Inc.
- Quantity
- 153
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1362-2026
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
U.S. Distribution to states of: CA, CO, IN, and NC.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Feb 25, 2026
- Recall initiation date
- Dec 18, 2025
- Center classification date
- Feb 13, 2026
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.