Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number:… — Class II medical device recall Z-1362-2026
Ongoing recall by Wilson-Cook Medical Inc., reported 2026-02-25, distributed in CA, CO, IN, NC. Due to product that may contain a void in the material that separates the wire guide and cutting wire lumens,
| Recall number | Z-1362-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Wilson-Cook Medical Inc., Winston Salem, NC, United States |
| Recall initiated | 2025-12-18 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-25 |
| Distributed | CA, CO, IN, NC |
| Quantity | 153 |
| UPC / GTIN / UDI-DI | 00827002607842, 00827002607859 |
| Model numbers | G60784, G60785, TESLA-B2535-260, TESLA-B2535-450 |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1362-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.