Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0369-2025 — 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 system. Catalog N

U.S. FDA — Device Enforcement · United States · 2024-10-04 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0369-2025
Date of alert
2024-10-04
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Corporation
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327117196
Reported risk: There is a potential for the product to activate without manual input when plugged into a power source or remain active after buttons are released. Unintentional activation of the device may result in localized burns to the patient or physician from electrical currents carried through conductive objects or fluids. Medical/surgical intervention may be needed to correct these injuries
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.