FDA Device recall Z-1097-2020
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004
- FDA Device
- Class II
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class II recall of SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004 by Stryker Instruments Div, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1097-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-01-13 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Stryker Instruments Div |
| Distribution | US |
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
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.
Identifiers
| code_info | 1921032 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1097-2020%22
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