FDA (Devices) recall action 68794
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.
Septodont is recalling Self-Etch bond because the material was incorrectly packaged.
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.
Septodont is recalling Self-Etch bond adhesive because the material was incorrectly packaged. The recall involves 60 units distributed to two wholesalers in Pennsylvania and New York.
Septodont is recalling 24 units of Compolite Bond SE dental adhesive because the material was incorrectly packaged. The product was distributed to wholesalers in Pennsylvania and New York.