Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal Recalled by Fujinon Inc Due to A limited number of endoscopes were shipped to...
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 Fujinon Inc directly.
Affected Products
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.
Quantity: 12 Units
Why Was This Recalled?
A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Fujinon Inc
Fujinon Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report