The Recall Desk
HighFDA (Devices)·Z-0367-2025·Announced 2024-11-20

Stryker smoke evacuation pencil recall: unintended activation risk

Stryker is recalling Neptune SafeAir Rocker-Switch Smoke Evacuation Pencils due to risk of unintended activation when plugged in or after button release, which may cause localized electrical burns requiring medical intervention.

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 credible risk of localized electrical burns from unintended activation. While no injuries have been reported, the hazard poses significant risk requiring potential medical intervention during surgery, meeting the criterion for a High-severity risk-of-harm recall.

Plain-English summary

Stryker Corporation is recalling the Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil (non-coated, 70mm model) due to a risk of unintended activation. The device may activate without manual input when plugged into a power source or remain active after buttons are released, contrary to proper operation.

Approximately 2,620 units have been distributed worldwide, including the United States, Canada, Japan, and Australia. The affected product is identified by Catalog Number 0703-047-001 and Lot Number 64117291.

Unintended activation of the device may result in localized electrical burns to patients or physicians caused by electrical currents conducted through conductive objects or surgical fluids. Medical or surgical intervention may be required to treat these injuries.

Healthcare facilities and physicians who have received this product should stop using it immediately and contact Stryker for instructions on return, replacement, or corrective action.

The recalled product

Product
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-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 sys
Manufacturer
Stryker Corporation
Category
Medical Device — Electrosurgical Equipment
Hazard
  • unintended-activation
  • electrical-burn
  • burn-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • GTIN: 07613327117219 Lot Number: 64117291

Distribution

Distributed nationwide across the United States.

Related recalls

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