FDA Device recall Z-0365-2025
Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including c…
- FDA Device
- Class II
- ongoing
- Published 2024-11-20
On 2024-11-20 the FDA classified a Class II recall of Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil, Coated, 70mm - Designed for general electrosurgical applications including c… 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-0365-2025 |
| 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 Rocker-Switch Smoke Evacuation Pencil, 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: 0703-047-000
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 | UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 538…UDI-DI: 07613327117202 Lot Numbers: 53863666 54409859 56319954 56945653 57699375 59053479 65178945 53863667 54409860 56319955 56945654 57699376 59053480 65178946 53863668 54409862 56319956 57699353 57699377 59053481 65178947 53863669 54409919 56319957 57699354 57699378 59053482 65178949 53863670 54409920 56319958 57699355 57699379 59053483 65347997 53863671 54409921 56319959 57699359 57699380 61288937 65784636 54403959 54409922 56319960 57699360 57699381 61288943 65784637 54403960 54409923 56319961 57699361 57699382 62825781 65784638 54403961 54409924 56892676 57699362 57805609 64117282 65784639 54403962 54409925 56892677 57699363 57805610 64477143 65876797 54403963 54409926 56892689 57699364 57805611 64477144 65961918 54403964 54409927 56932527 57699365 58320366 64477145 66133414 5440 |
|---|
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-0365-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.