FDA (Devices) recall action 76497
The FDA (Devices) publishes a recall like this one as 5 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 5 pages.
Handle may break during use.
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.
Medtronic is recalling SharkCore LG Fine Needle Biopsy Systems because the handle may break during use.
Medtronic is recalling 1,096 units of BNX Fine Needle Aspiration Systems because the handle may break during use.
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use, posing a risk of injury to patients or providers.
Medtronic is recalling SharkCore Fine Needle Biopsy Systems because the handle may break during use. The recall covers 1,096 units distributed in the US and two countries.
Medtronic is recalling 1,096 BNX Fine Needle Aspiration Systems because the handle may break during use.