Drug recall
Teslatome Bipolar Sphincterotomes REF: TESLA-B2535-260 Model Number: G60784 UDI-DI code: 00827002607842 REF…
FDA recall event 98202 · Class II · Wilson-Cook Medical Inc.
Key facts
| Event ID | 98202 |
|---|---|
| Recall numbers | Z-1362-2026 |
| Recalling firm | Wilson-Cook Medical Inc. |
| Product type | Devices |
| Products | 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… |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| 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. |
| Initiation date | Dec 18, 2025 |
| Report date | Feb 25, 2026 |
| City | Winston Salem |
| State | NC |
| Country | United States |
| FEI number | 1037905 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: