Stryker Neptune SafeAir Smoke Evacuation Pencil May Activate Unintentionally
Stryker recalls Neptune SafeAir Smoke Evacuation Pencils that may activate without user input, risking electrical burns to patients or healthcare workers. Approximately 1,996,010 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 risk-of-harm medical device where injury has not yet been reported. Although classified as FDA Class II, it poses a clear hazard of electrical burns requiring potential medical intervention if unintended activation occurs, but without documented illnesses or injuries.
Plain-English summary
Stryker Corporation is recalling approximately 1,996,010 Neptune SafeAir Smoke Evacuation Pencils due to a potential activation defect. The device, designed for electrosurgical applications including cutting and coagulation with integrated smoke evacuation, may activate unintentionally when plugged into a power source or remain active after buttons are released.
Unintended activation of the electrosurgical device can result in localized electrical burns to patients or healthcare workers from electrical currents carried through conductive objects or fluids. Medical or surgical intervention may be required to treat injuries caused by this hazard.
The affected units were distributed worldwide to the United States, Canada, Japan, and Australia. Specific lot numbers and instructions for device management are available through the FDA and Stryker Corporation.
The recalled product
- Product
- Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - Designed for general electrosurgical applications including cutting and coagulation and for removing smoke generated by electrosurgery when used in conjunction with an effective smoke…
- Manufacturer
- Stryker Corporation
- Affected units
- 1,996,010
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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