Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fujifilm Medical Systems Duodenoscope Recalled by Fujifilm Medical Systems U.S.A., Inc. Due to A precautionary measure because the Duodenoscopes have been...
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 Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
Quantity: 79 units (US) and 985 units (Internationally)
Why Was This Recalled?
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
Where Was This Sold?
This product was distributed to 13 states: CA, CO, FL, IL, IA, KS, LA, MD, MN, MO, NC, TN, WA
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