Stryker Neptune SafeAir Rocker-Switch Smoke Evacuation Pencil — Class II medical device recall Z-0365-2025
Ongoing recall by Stryker Corporation, reported 2024-11-20, distributed nationwide. There is a potential for the product to activate without manual input when plugged into a power source or rema
| Recall number | Z-0365-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2024-10-04 |
| Classified | 2024-11-13 |
| Reported by FDA | 2024-11-20 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, JP |
| Quantity | 1,120,860 eaches |
| UPC / GTIN / UDI-DI | 07613327117202 |
| Lot numbers | 53863666, 53863667, 53863668, 53863669, 53863670, 53863671, 54403959, 54403960, 54403961, 54403962, 54403963, 54403964, 54403965, 54409851, 54409852, 54409853, 54409854, 54409855, 54409856, 54409857, 54409858, 54409859, 54409860, 54409862, 54409919, 54409920, 54409921, 54409922, 54409923, 54409924, 54409925, 54409926, 54409927, 54533880, 54533881, 54533882, 54533883, 54533884, 54654973, 54665296 and 143 more |
| Model numbers | 0703-047-000 |
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 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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0365-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.