The firm told FDA that select lots may carry a protrusion that could cause genitourinary trauma. The record names process control as the cause, which is the answer FDA's file gives more often than any other.
Every factual claim links to a primary source, standards are cited by number and year, and sponsored and contributed pieces carry a label. That is the whole method, and it is written out on the ethics policy.
This section has its own feed at /news/feed. The FDA data on this site does not wait for the newsroom: clearances, recalls, product codes and company records are live at the data hub.