FDAClass IISeptember 20, 2017

Fujifilm Endoscope recall

Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI…

Why was Fujifilm Endoscope recalled?

Fujifilm is conducting a corrective action due to an FDA inspection.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

will be entered.

Product
Fujifilm Endoscope Models ED-250XL5 ED-250XT5 ED-450XT5 ED-450XL5 Product Usage: This product is a medical endoscope for the duodenum and upper GI…
Recalling firm
Fujifilm Medical Systems U.S.A., Inc.
Quantity
260 manuals in total
Distribution
US Nationwide Distribution
Recall date
September 20, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls