FDA recall Z-0366-2025

Stryker Corporation · Class II · device

Product

Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, 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. Catalog Number: 0703-047-002

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

Distribution

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

Key facts

Status
Ongoing
Initiation date
2024-10-04
Report date
2024-11-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Portage, MI, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0366-2025