Stryker Smoke Evacuation Pencils Recalled for Unintended Activation Risk
Stryker is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units because they may activate unexpectedly when plugged in, creating a risk of electrical burns to patients and physicians.
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 with potential for serious injury (localized electrical burns and possible need for medical intervention), but no reported illnesses or injuries to date. This fits the High severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Stryker Corporation is recalling 403,730 Neptune SafeAir Smoke Evacuation Pencil units used in surgical settings to remove electrosurgery smoke. The devices are designed for general electrosurgical applications.
The recalled pencils have a potential defect causing them to activate without manual user input when plugged into a power source, or to remain active after the buttons are released. This unintended activation can result in localized electrical burns to patients or surgeons from electrical currents transmitted through conductive objects or surgical fluids.
The affected products have been distributed worldwide, including throughout the United States, Canada, Japan, and Australia. The recall includes products bearing specific lot numbers. Medical or surgical intervention may be required to treat resulting injuries.
The recalled product
- Product
- 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 evacuatio
- Manufacturer
- Stryker Corporation
- Hazard
- unintended-activation
- electrical-shock
- burn-injury
Distribution
Distributed nationwide across the United States.
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