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

Recall Insight

This FDA Devices action (record #Z-0369-2025) was formally reported on November 20, 2024, with the manufacturer initiating the action on October 4, 2024. It is classified under Moderate severity (Class II), with a current status of Ongoing. Stryker Corporation is listed as the recalling firm, operating out of Portage, MI. Federal records indicate 21,490 eaches units are affected.

The documented reason for this recall is: 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… Distribution data in the federal record shows the product reached: Worldwide distribution - US Nationwide and the countries of Canada, Japan, Australia.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.