FDA (Devices) recall action 82099
The FDA (Devices) publishes a recall like this one as 4 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 4 pages.
The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
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 two TJF-Q180V duodenoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the device's durability or effectiveness.
Olympus is recalling one GIF-H180J videoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.
Olympus is recalling two video colonoscopes because the adhesive used in their repair was incorrectly prepared, potentially affecting the durability of the repair.
Olympus is recalling one ultrasound gastrovideoscope because the adhesive used for its repair was incorrectly prepared, potentially affecting the device's durability.