FDA (Devices) recall action 84721
The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Stryker is recalling Telescopic Smoke Evac Pencils because hairline fractures could cause electrical current to arc, potentially burning patients or users.
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.
Stryker is recalling 15,150 telescopic Bovie pencils due to hairline fractures that could cause electrical arcing and burns.