Medical device recalls Moderate risk

Stryker Corporation recalls Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical appl…

Recall date
October 4, 2024
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0365-2025
FDA classification
Class II
Brand / firm
Stryker Corporation
Sold / distributed
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, 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: 0703-047-000

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