Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm - Designed for general electrosurgical a
Summary
The FDA issued a Class II for Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Non-coated, 70mm by Stryker Corporation. 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. Un.
Details
Source
Device Recall
External ID
Z-0367-2025
Action Date
2024-11-20
Status
Ongoing
Category
device
Product Description
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
Lot/Code Info: GTIN: 07613327117219 Lot Number: 64117291
Quantity Affected: 2,620 eaches
Reason for Recall
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
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-10-04
Company
Portage, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 242 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Stryker Corporation) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Stryker Corporation have FDA actions?
Stryker Corporation has 98 FDA actions in our database, including 90 recalls and 8 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0367-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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