Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to The suction button on the ED-530XT endoscope may...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Fujifilm Medical Systems U.S.A., Inc. directly.
Affected Products
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Quantity: 256 units
Why Was This Recalled?
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
Where Was This Sold?
Distributed in the US and Canada.
About Fujifilm Medical Systems U.S.A., Inc.
Fujifilm Medical Systems U.S.A., Inc. has 37 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report