FDA (Devices) recall action 73684
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.
Reports relating to unintended patient or operator burns or operator electric shock for some of Integra's MicroFrance electrosurgical instruments.
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.
Integra LifeSciences is recalling 2,487 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.
Integra LifeSciences is recalling 30,146 MicroFrance electrosurgical instruments due to reports of unintended patient or operator burns and electric shock.