FDAFDA · Food and drugs·Recall number Z-0367-2025
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
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: 07613327117219 Lot Number: 64117291
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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