FDA (Devices) recall action 84735
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.
Distributed in the USA without an approved 510K
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.
Pentax of America Inc is recalling one unit of the EC38-i10L Video Colonoscope because it was distributed in the USA without an approved 510(k).
Pentax of America Inc is recalling specific Pentax Video Colonoscopes because they were distributed in the USA without an approved 510K.