FDAFDA · Food and drugs·Recall number Z-0369-2025
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
Published November 20, 2024 · Recall initiated: October 4, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Stryker Corporation
- Distributor
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
- Lot
- GTIN: 07613327117196 Lot Numbers: 53867671 54409847 59053476 64855502 66494932
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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