# FDA recall Z-1467-2025

> **Checkpoint Surgical Inc** · Class II · device recall initiated 2025-02-24.

## Product

Brand Name: Checkpoint Guardian Intraoperative Lead  Product Name: Checkpoint Guardian Intraoperative Lead, Medium  Model/Catalog Number: REF# 9525 (Medium)  Product Description: The Checkpoint Guardian Intraoperative Leads are single-patient disposable accessories for  providing stimulus to a targeted nerve. The accessories are intended for use with any device from  the Checkpoint Stimulator/Locator Family. The lead electrode is intended to wrap around nerves  that have been surgically exposed, allowing the surgeons to provide hands free stimulus to a  targeted nerve.

## Reason for recall

Adhesive on the back of the lead may not fully encapsulate the metallic portion of the wire and button subassembly, potentially leading to exposed metal. There is a risk of electrical current leakage, which may lead to inconsistent or confusing muscle responses, potentially compromising the effectiveness of the intended use as the surgeon could take an incorrect clinical action.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1467-2025
- **Recalling firm:** Checkpoint Surgical Inc
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2025-02-24
- **Report date:** 2025-04-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Cleveland, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1467-2025

## Citation

> AI Analytics. FDA recall Z-1467-2025. Retrieved 2026-07-27 from https://api.ai-analytics.org/recall/Z-1467-2025. Source: US FDA. Licensed CC0.

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