FDA Device recall Z-0368-2025
Stryker Neptune SafeAir Smoke Evacuation Pencil, Coated, 70mm Blade, Push Button Switch - 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, 70mm Blade, Push Button Switch - 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-0368-2025 |
| 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, 70mm Blade, Push Button Switch - 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: 0703-046-000
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: 07613327117202 Lot Numbers: 54409778 59692168 62016967 63292654 64324200 64855491 65961907 67325428 5…GTIN: 07613327117202 Lot Numbers: 54409778 59692168 62016967 63292654 64324200 64855491 65961907 67325428 57699286 60313543 62016978 63292655 64324201 64855498 65961908 67377503 57738329 60313544 62296666 63632847 64324207 64855499 65961909 67481708 57738330 60313545 62296667 63632848 64324208 64855500 66012917 67481709 57738331 60313546 62296668 63632851 64354844 64855501 66012918 67481710 57738332 60313547 62382103 63632852 64354845 64973248 66133412 67481711 57738333 60313549 62382104 63842616 64354846 64973249 66387344 67481712 57738334 60834119 62382105 63842618 64354847 64973253 66494921 67652608 58014507 60834120 62678399 63842619 64354850 64973254 66494922 67652609 58014508 60834121 62678400 63842620 64354851 64973255 66494923 67722909 58014509 60834122 62678401 63871520 64477131 64973256 66494924 67794511 58014519 60834123 62678402 63871521 |
|---|
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-0368-2025%22
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