Stryker electrosurgical smoke evacuation pencils recalled for unintended activation risk
Stryker is recalling smoke evacuation pencils used in electrosurgery that may activate without manual input, creating a risk of electrical burns to patients or healthcare providers.
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 recall involving risk of serious electrical burn injury from unintended device activation. The source text explicitly states the device 'may result in' injuries with no reported cases, making this a theoretical hazard. Per the rubric, risk-of-harm products without reported injury are scored at most 3.
Plain-English summary
Stryker Corporation is recalling the Neptune SafeAir Smoke Evacuation Pencil with a Coated Rocker-Switch (Catalog Number 0703-047-002) in bulk non-sterile configuration. The recall affects approximately 295,760 units distributed worldwide, including in the United States, Canada, Japan, and Australia.
The device may activate without manual input when plugged into a power source or may remain active after the buttons are released. This unintentional activation can deliver electrical currents through conductive objects or fluids, resulting in localized burns to the patient or physician.
Healthcare facilities and users who have received affected units should discontinue use immediately. Stryker is investigating the root cause. Medical or surgical intervention may be needed to treat any burns that have occurred. For assistance, users should contact Stryker Corporation.
The recalled product
- 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 evacuat
- Manufacturer
- Stryker Corporation
- Hazard
- unintended-activation
- burn-injury
Distribution
Distributed nationwide across the United States.
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