# FDA recall Z-2253-2023

> **Wilson-Cook Medical Inc.** · Class II · device recall initiated 2023-06-22.

## Product

Fusion Lithotripsy Extraction Basket, Model Number FS-LXB-3X6 G48278; Fusion Lithotripsy Extraction Baskets are intended to be used for endoscopic removal of biliary stones and foreign bodies.

## Reason for recall

Non-conforming product may appear in the field as inability to advance or retract the basket, or the drive wire breaking or separating from handle (with or without mechanical lithotripsy).

## Distribution

Worldwide distribution.

## Key facts

- **Recall number:** Z-2253-2023
- **Recalling firm:** Wilson-Cook Medical Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-22
- **Report date:** 2023-08-09

- **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-2253-2023

## Citation

> AI Analytics. FDA recall Z-2253-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-2253-2023. Source: US FDA. Licensed CC0.

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