CLASS II Device recall · Reported 12 Feb 2020 · FDA Enforcement Report
SafeAir Telescopic Smoke Evacuation Pencil, Product No. recalled
Stryker Instruments Div. of Stryker is recalling SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004, distributed nationwide in the US. The recall was initiated on 13 Jan 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1097-2020
- FDA event ID
- 84721
- Recalling firm
- Stryker Instruments Div. of Stryker, Portage, MI
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Jan 2020
- FDA classified
- 6 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 13 Jan 2020 | Recall initiated by company | |
| 6 Feb 2020 | Classified by FDA | +24 days |
| 12 Feb 2020 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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
Where it was distributed
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
1921032
Where was it sold?
Domestic distribution nationwide. Foreign distribution to Netherlands and Australia.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 84721| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Telescopic Uncoated (Push Button), Product No. SHK TSPL recalled | Stryker Instruments Div. of Stryker | Other | Nationwide | |
| CLASS II | Telescopic Smoke Evac Pencil, PB, Coated, Product No. Shktspcl recalled | Stryker Instruments Div. of Stryker | Other | Nationwide |
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|---|---|---|---|---|---|
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