SafeAir Telescopic Smoke Evacuation Pencil — Class II medical device recall Z-1097-2020
Terminated recall by Stryker Instruments Div. of Stryker Corporation, reported 2020-02-12, distributed nationwide. Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn
| Recall number | Z-1097-2020 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Instruments Div. of Stryker Corporation, Portage, MI, United States |
| Recall initiated | 2020-01-13 |
| Classified | 2020-02-06 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2021-08-10 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, NL |
| Quantity | 15,150 |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 37613327466332 |
Product
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
Reason for recall
Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user.
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-1097-2020. 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.