FDA (Devices) recall action 79701
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.
Breakage of the endoscope's insertion tube bending section during surgical procedures.
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.
Olympus is recalling 2,399 Uretero-reno fiberscopes because the insertion tube bending section may break during surgery.
Olympus is recalling 1,062 Uretero-reno fiberscopes URF-P6 because the insertion tube bending section may break during surgery.