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Recall Observatory FDA recall evidence

Device 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 system. Catalog Number: 0703-046-001

Z-0369-2025

October 04, 2024

Class II

Product summary

Firm
Stryker Corporation
Event
Event 95502
Status
Ongoing
Classification
Class II
Quantity
21,490 eaches
Official record key
device-enforcement:Z-0369-2025

Official wording

Reason: 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

Code information: GTIN: 07613327117196 Lot Numbers: 53867671 54409847 59053476 64855502 66494932

Distribution pattern: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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