Fujifilm Processor EPX 2500 High Definition Endoscopy; (Sales Brochure). For use in endoscopic procedures. Used to observe, record and capture images.

Recall Insight

This FDA Devices action (record #Z-2806-2015) was formally reported on September 30, 2015, with the manufacturer initiating the action on June 30, 2015. It is classified under Moderate severity (Class II), with a current status of Terminated. Fujifilm Medical Systems U.S.A., Inc. is listed as the recalling firm, operating out of Wayne, NJ. Federal records indicate multiple units are affected.

The documented reason for this recall is: The EPX-2500 Operation Manual and sales brochure incorrectly identify that the ED-530XT endoscope is meant to be used with the EPX-2500 Processor. The Operation Manual and sales brochure state that when the ED-530XT en… Distribution data in the federal record shows the product reached: Nationwide US and Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 11 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.