FDA (Devices) recall action 68495
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.
Potential for the Fenestrated Grasper Tip jaw to break when force is applied to the jaw
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.
Microline Surgical is recalling ReNew Laproscopic Fenestrated Grasper Forceps Tips because the jaw may break when force is applied.
Microline Surgical is recalling 150 units of ReNew Laproscopic Fenestrated Grasper Forceps Tips because the jaw may break when force is applied.