Duodenoscopes recalled

The recall of ED-530XT duodenoscopes by Fujifilm includes replacement of the ED-530XT forceps elevator mechanism (including the O-ring seal), replacement of the distal end cap, and new operation manuals.


The FDA on July 21 cleared the updated design and labeling for ED-530XT duodenoscopes by Fujifilm, but the manufacturer on the same day informed customers that it was recalling all of the devices.

Customers were sent an urgent medical device correction and removal notification of the recall, which includes replacement of the ED-530XT forceps elevator mechanism (including the O-ring seal), replacement of the distal end cap, and new operation manuals.

After receiving the new operation manuals, customers who received the notice should remove, replace, and destroy any older operation manuals, the FDA recommends. The agency outlined validated manual reprocessing instructions, which facilities should continue to use when cleaning and disinfecting the duodenoscopes, in a December 2015 safety communication.