# FDA recall Z-1362-2026

> **Wilson-Cook Medical Inc.** · Class II · device recall initiated 2025-12-18.

## 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.

## Distribution

U.S. Distribution to states of: CA, CO, IN, and NC.

## Key facts

- **Recall number:** Z-1362-2026
- **Recalling firm:** Wilson-Cook Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-12-18
- **Report date:** 2026-02-25

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Winston Salem, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1362-2026

## Citation

> AI Analytics. FDA recall Z-1362-2026. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1362-2026. Source: US FDA. Licensed CC0.

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