FDA (Devices) recall action 72106
The FDA (Devices) publishes a recall like this one as 2 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 2 pages.
There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
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.
MicroAire Surgical Instruments is recalling three LipoTower units with aspiration pumps due to a potential risk of electrical shock if internal lead wires detach.
MicroAire Surgical Instruments is recalling 168 LipoTower units due to a risk of electrical shock if internal lead wires detach and the ground connection fails.