Stryker Neptune SafeAir Electrosurgical Pencil Recalled for Unintended Activation Risk
Stryker has recalled over 1.1 million Neptune SafeAir Smoke Evacuation Pencils due to potential unintended activation that may cause electrical burns to patients and surgical staff. The device may activate without user input or remain active after buttons are released.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device with potential for serious electrical burns; this represents a risk-of-harm product where the hazard is credible but injuries have not been reported.
Plain-English summary
Stryker Corporation has recalled the Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm (Catalog Number 0703-047-000). This is a medical device designed for general electrosurgical applications including cutting and coagulation, and for removing smoke during electrosurgery when used with an effective smoke evacuation system. Approximately 1,120,860 units are affected worldwide.
The recalled devices have a potential defect: the device may activate without manual input when plugged into a power source or remain active after buttons are released. This unintended activation can allow electrical currents to be carried through conductive objects or fluids, creating a hazard to patients and surgical staff.
Unintended activation may result in localized electrical burns to the patient or surgical staff. Medical or surgical intervention may be needed to treat such injuries. Affected units are identified by numerous lot numbers. Healthcare providers using this device should immediately discontinue use and contact Stryker for instructions regarding device replacement or return.
The recalled product
- Product
- 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.
- Manufacturer
- Stryker Corporation
- Hazard
- unintended-activation
- electrical-burn
- electrical-hazard
Distribution
Distributed nationwide across the United States.
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