# FDA recall Z-0367-2025

> **Stryker Corporation** · Class II · device recall initiated 2024-10-04.

## Product

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke evacuation system.    Catalog Number: 0703-047-001

## Reason for recall

There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents  carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries

## Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

## Key facts

- **Recall number:** Z-0367-2025
- **Recalling firm:** Stryker Corporation
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-10-04
- **Report date:** 2024-11-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Portage, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0367-2025

## Citation

> AI Analytics. FDA recall Z-0367-2025. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-0367-2025. Source: US FDA. Licensed CC0.

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