Z-0708-06

Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal...

Name: Z-0708-06 Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal...
Creator: Fujinon Inc
Published: 2006-03-27
License: https://open.fda.gov/license/

FUJIFILM Healthcare Americas Corporation / initiated 2006-03-27 / Terminated

FDA source

Fujinon Inc began a recall of Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes on 2006-03-27. The reason FDA records is "Colonoscope insertion tube is not bending properly and is stiff". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0708-06
Status: Terminated
Initiated: 2006-03-27
Posted: 2006-04-05
Terminated: 2007-12-03
Recalling firm: FUJIFILM Healthcare Americas Corporation
Product: Fujinon Endoscope Insertion Tube included with lower gastrointestinal EVE and lower gastrointestinal electronic video endoscopes.
Product code: FDF Colonoscope And Accessories, Flexible/Rigid
Reason for recall: Colonoscope insertion tube is not bending properly and is stiff.
FDA root cause: Other
Action: 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.
Quantity in commerce: 2335 UNITS
Distribution: Product is distributed nationwide to hospitals and physicians. It was shipped internationally to Canada. US Government accounts include VA medical centers in Spokane WA, St. Louis, MO and Camp Pendleton Naval Hospital in Camp Pendleton, CA.
Product codes and lots: Catalog Numbers: EC-450HL5; EC-450LP5; EC-250HL5; EC-250LP5; EC-450HL5-UP; EC-450LP5-UP; EC-250HL5-UP; EC-250LP5-UP. All lots

Product code FDF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)