Stryker Telescopic Bovie Pencil Recalled for Electrical Arcing Risk
Stryker is recalling 15,150 telescopic Bovie pencils due to hairline fractures that could cause electrical arcing and burns.
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 burns to patients and users, which aligns with the rubric criteria for Severe severity (Class II with potential for significant injury).
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 15,150 units of the Telescopic Uncoated (Push Button) Bovie pencil, Product No. SHK TSPL. The device is a 75-inch compressed telescoping shaft used for medical procedures. The recall is classified as Class II by the FDA.
The recall was initiated because hairline fractures in a component could allow electrical current to arc out of the device. This malfunction poses a risk of burns to the patient and/or user. The affected units were distributed domestically nationwide and internationally to the Netherlands and Australia.
Healthcare providers and facilities should stop using the affected devices immediately. The specific lot codes associated with this recall are 1922042, 1924003, 1929040, and 1929048. Users should contact Stryker for instructions on returning or replacing the equipment.
The recalled product
- Product
- Telescopic Uncoated (Push Button), Product No. SHK TSPL. 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 (4)
- 1922042
- 1924003
- 1929040
- 1929048
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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