Stryker Neptune SafeAir smoke evacuation pencil recalled for unintended activation
Stryker Corporation is recalling 21,490 Neptune SafeAir Smoke Evacuation Pencils due to risk of unintended activation that could cause electrical burns. 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: This is a Class II device recall with a risk-of-harm defect (unintended electrical activation causing burn injuries). The source text does not report any actual injuries or illnesses, meeting the rubric criterion of 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Stryker Corporation is recalling the Neptune SafeAir Smoke Evacuation Pencil (catalog number 0703-046-001), an electrosurgical device used for cutting, coagulation, and smoke evacuation during surgery. Approximately 21,490 units are affected, distributed worldwide including the United States, Canada, Japan, and Australia.
The device may activate without user input when plugged in or remain active after buttons are released. This unintended activation poses a risk of localized electrical burns to patients or physicians through exposure to electrical currents in conductive objects or fluids, potentially requiring medical or surgical intervention.
Affected lot numbers are 53867671, 54409847, 59053476, 64855502, and 66494932. Additional product information is available via catalog number 0703-046-001 and GTIN 07613327117196.
The recalled product
- Product
- Stryker Neptune SafeAir Smoke Evacuation Pencil Non coated 70 mm Blade Push-Button - 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
- Manufacturer
- Stryker Corporation
- Affected units
- 21,490
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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