Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2017 - (Recall #: Z-3129-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

Product Description:

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 tract. It is intended for observation, diagnosis, and endoscopic treatment of the esophagus, stomach and duodenum. This product is not used for any other purposes.

Product Classification:

Class II

Date Initiated: March 9, 2015

Date Posted: September 20, 2017

Recall Number: Z-3129-2017

Event ID: 76905

Reason for Recall:

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

Status: Terminated

Product Quantity: 260 manuals in total

Code Information:

will be entered.

Distribution Pattern:

US Nationwide Distribution

Voluntary or Mandated:

Voluntary: Firm initiated