Stryker SafeAir Telescopic Smoke Evacuation Pencil Recalled for Burn Risk
Stryker is recalling SafeAir Telescopic Smoke Evacuation Pencils because hairline fractures in a component could allow electrical current to arc, potentially causing burns to patients or users.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury (burns) to patients and users, which aligns with the 'Severe' criteria for significant injury reports or high-risk device defects.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling the SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long when compressed, featuring a telescoping shaft. The recall involves 15,150 units distributed domestically nationwide and internationally to the Netherlands and Australia.
The recall is being conducted because hairline fractures in a component of the device could allow electrical current to arc out of the device. This malfunction could result in a burn to the patient and/or user.
Healthcare facilities and users should stop using the affected devices immediately. Stryker is the recalling firm responsible for managing the recall process.
The recalled product
- 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
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 15,150
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1921032
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Stryker Instruments Div. of Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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