FDA (Devices) recall action 97792
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.
A manufacturing issue could lead to a malformed cover tube press which can lead to internal components' movement during firing - leading to the potential for uncontrolled motion.
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.
Covidien is recalling 3,263 Signia Small Diameter Curved Tip Intelligent Reloads because a manufacturing issue can allow internal components to move during firing, risking uncontrolled motion.
Covidien is recalling two units of a VATS lobectomy box containing the Signia Small Diameter Curved Tip Intelligent Reload because internal components may move during firing.