Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2015 - (Recall #: Z-2778-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.

Product Classification:

Class II

Date Initiated: June 30, 2015

Date Posted: September 23, 2015

Recall Number: Z-2778-2015

Event ID: 71695

Reason for Recall:

The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.

Status: Terminated

Product Quantity: 256 units

Code Information:

ED-530XT - Part #202B1237697D; ED-250XT5 and ED-250XL5 - Part #202B1260196A; ED-450XT5 - Part #202B1260211A and ED-450XL5 - Part #202B1237681

Distribution Pattern:

Distributed in the US and Canada.

Voluntary or Mandated:

Voluntary: Firm initiated