FDA (Devices) recall action 83774
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 mismatch between the angle of the hole in the base and the angle of the bell, which may cause the clamp to remove foreskin without the use of a scalpel.
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.
Centurion Medical Products is recalling 1,530 Circlamps due to a design mismatch that may cause the device to remove foreskin without a scalpel.
Centurion Medical Products is recalling 204 units of the CIRCLAMP W/1.3 CM BELL because a design mismatch may cause the clamp to remove foreskin without a scalpel.