Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - Designed for...
FDA Recall #Z-0369-2025 — Class II — October 4, 2024
Product Description
Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - 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: 0703-046-001
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
Recalling Firm
Stryker Corporation — Portage, MI
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
21,490 eaches
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Code Information
GTIN: 07613327117196 Lot Numbers: 53867671 54409847 59053476 64855502 66494932
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated