FDA Medical devices recall ·
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated… recall
- Recall number
- Z-0367-2025
- Date
- (initiated October 4, 2024)
- Company / brand
- Stryker Corporation
1941 Stryker Way, Portage, MI, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2,620 eaches
- Hazard tags
- Burn Injury risk
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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 system. Catalog Number: 0703-047-001
Why was it recalled?
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
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
GTIN: 07613327117219 Lot Number: 64117291
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-0367-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.