FDA (Devices) recall action 69404
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.
Product is not cleared for use with lasers other than the Auriga XL system
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.
Boston Scientific is recalling 7 units of StarMedTec LightTrail Reusable Fibers because they are not cleared for use with lasers other than the Auriga XL system.
Boston Scientific is recalling 5 units of StarMedTec LightTrail Reusable Fibers because they are not cleared for use with lasers other than the Auriga XL system.
Boston Scientific is recalling 33 units of StarMedTec LightTrail Reusable Fibers because the product is not cleared for use with lasers other than the Auriga XL system.