The Recall Desk
HighFDA (Devices)·Z-1098-2020·Announced 2020-02-12

Stryker Telescopic Smoke Evac Pencil Recalled for Electrical Arcing Risk

Stryker is recalling Telescopic Smoke Evac Pencils because hairline fractures could cause electrical current to arc, potentially burning patients or users.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a risk-of-harm product (electrical burn) where injury has not yet been reported, fitting the High severity criteria.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling the Telescopic Smoke Evac Pencil, Product No. SHKTSPCL. This medical device is a Bovie pencil with a telescoping shaft that is 75 inches long when compressed. The recall involves 15,150 units distributed domestically in the United States and internationally to the Netherlands and Australia.

The recall is due to a potential defect where hairline fractures in a component could allow electrical current to arc out of the device. This malfunction could result in a burn to the patient and/or the user. The affected units are identified by the following lot codes: 1923011, 1923050, 1924004, 1924005, 1924015, 1929038, 1929039, and 1929055.

Healthcare facilities and users should stop using the affected devices immediately. Stryker is responsible for managing the recall and will contact customers to arrange for the return or replacement of the units. Consumers and medical professionals should verify their inventory against the listed lot codes to ensure compliance with the recall.

The recalled product

Product
Telescopic Smoke Evac Pencil, PB, Coated, Product No. SHKTSPCL. 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
Category
Medical Device — Surgical Instruments
Hazard
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 (8)

  • 1923011
  • 1923050
  • 1924004
  • 1924005
  • 1924015
  • 1929038
  • 1929039
  • 1929055

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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Stryker Instruments Div. of Stryker Corporation

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Same hazard · burn injury

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