Fujifilm Medical Systems U.S.A., Inc.: Medical Device Recall in 2016 - (Recall #: Z-1860-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

Endoscope; ED-530XT Operation Manual 'Operation and Preparation' and 'Cleaning, Disinfection and Storage'

Product Classification:

Class II

Date Initiated: December 23, 2015

Date Posted: June 8, 2016

Recall Number: Z-1860-2016

Event ID: 73469

Reason for Recall:

This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.

Status: Terminated

Product Quantity: 1473 units

Code Information:

All distribution dates :3/2003-4/2016

Distribution Pattern:

Nationwide Distribution.

Voluntary or Mandated:

Voluntary: Firm initiated