Fujinon Inc Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
Brand
Fujinon Inc
Lot Codes / Batch Numbers
Catalog Numbers: EC-450HL5, EC-450LP5, EC-250HL5, EC-250LP5, EC-450HL5-UP, EC-450LP5-UP, EC-250HL5-UP, EC-250LP5-UP. All lots
Products Sold
Catalog Numbers: EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP. All lots
Fujinon Inc is recalling Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal due to Colonoscope insertion tube is not bending properly and is stiff.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Colonoscope insertion tube is not bending properly and is stiff.
Recommended Action
Per FDA guidance
Fujinon sent out a Technical Bulletin on 3/27/2006 that instructs the physician to do a bending test with the colonoscope. If the scope does not bend around an 8 inch bending diameter, the scope is not to be used.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026