Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button recalled over sterility concerns

Recall date

October 4, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Stryker Corporation recalls Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - Designed for general electrosurg…

Recall number

Z-0370-2025

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 Smoke Evacuation Pencil Coated Push-Button, Bulk Non-sterile - 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. The pencil enables the operator to remotely conduct an electrosurgical current from the output connector of an electrosurgical unit to the operative site for the desired surgical effect. Catalog Number: 0703-046-002