Fujinon Inc: Medical Device Recall in 2013 - (Recall #: Z-0112-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal and peripheral organs of the upper gastrointestinal tract for observation, diagnosis and endoscopic treatment.

Product Classification:

Class II

Date Initiated: July 31, 2013

Date Posted: November 6, 2013

Recall Number: Z-0112-2014

Event ID: 66144

Reason for Recall:

A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set screws used to more securely attach the Forceps Inlet (biopsy inlet port) to the endoscope.

Status: Terminated

Product Quantity: 12 Units

Code Information:

Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029

Distribution Pattern:

Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.

Voluntary or Mandated:

Voluntary: Firm initiated