FDA Device recall Z-0366-2025
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications…
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - Designed for general electrosurgical applications… by Stryker, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0366-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-10-04 |
| Published | 2024-11-20 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Stryker |
| Distribution | US |
Product
Stryker Neptune SafeAir Smoke Evacuation Pencil Coated Rocker-Switch, Bulk Non-Sterile - 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: 0703-047-002
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
Identifiers
| code_info | GTIN: 07613327379471 Lot Numbers: 53700305 53864207 53864241 53864247 60308905 62012084 64112630 65342955…GTIN: 07613327379471 Lot Numbers: 53700305 53864207 53864241 53864247 60308905 62012084 64112630 65342955 53700306 53864212 53864243 53864248 60308906 62291715 64112631 65869470 53700307 53864213 53864244 53864249 60308907 62291717 64142443 65869471 53700308 53864214 53864245 53864257 61283868 62821201 64968515 65954806 53864205 53864219 53864246 60308904 61283869 64112629 64968516 66005707 53864206 Additional Lot Numbers: 64917537 65342956 66487443 67787272 67840867 68672644 64917538 66487442 67787271 67840866 67840868 68672645 |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0366-2025%22
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