FDA (Devices) recall action 80925
The FDA (Devices) publishes a recall like this one as 30 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 30 pages.
The attachment of non-Olympus accessories to the bronchoscope s instrument channel port may have resulted in more applied force than expected and lead to loosening of the instrument channel port.
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 2,163 Bronchovideoscope BF-P240 units because using non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,461 Bronchovideoscope BF-XP160F units because using non-Olympus accessories may cause the instrument channel port to loosen.
Olympus is recalling 861 Bronchovideoscope BF-XT160 units because using non-Olympus accessories may have caused the instrument channel port to loosen.
Olympus is recalling 2,479 Bronchovideoscope BF-3C40 units because attaching non-Olympus accessories may loosen the instrument channel port.
Olympus is recalling 1,296 Bronchofiberscope BF-XP60 units because using non-Olympus accessories may cause the instrument channel port to loosen.