FDA (Devices) recall action 94831
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.
Some foil pouches were found torn open, impacting the sterile barrier which was traced to a specific machine used during product packaging.
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.
Ethicon Sarl is recalling SURGICEL FIBRILLAR product due to torn foil pouches that compromised the sterile barrier. Approximately 39,010 units distributed in the US, India, and Japan are affected.
Ethicon is recalling SURGICEL FIBRILLAR hemostatic pads due to torn foil pouches that compromise the sterile barrier, traced to a specific packaging machine defect.