Z-0367-2025 Class II Ongoing
FDA device recall Z-0367-2025 was initiated by Stryker Corporation on Oct 4, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 2,620 eaches.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 20, 2024
- Initiation Date
- Oct 4, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,620 eaches
Product Description
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 Pattern
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Code Information
GTIN: 07613327117219 Lot Number: 64117291
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0367-2025
- openFDA file date
- Oct 6, 2026
- Loaded by RegDataLab
- Oct 12, 2026