The Recall Desk
HighFDA (Devices)·Z-0112-2014·Announced 2013-11-06

Fujinon Ultrasonic Endoscope Recall for Missing Set Screws

Fujinon Inc is recalling 12 ultrasonic endoscopes due to missing set screws that secure the biopsy inlet port.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a structural defect in a medical device that could compromise the integrity of the biopsy port, representing a risk of harm where injury has not yet been reported.

Plain-English summary

Fujinon Inc is recalling 12 units of the Fujinon/Fujifilm Ultrasonic Endoscope (Model EG-530UT2). The recall is due to a manufacturing defect where set screws used to securely attach the Forceps Inlet (biopsy inlet port) to the endoscope were missing.

The affected devices were distributed worldwide, including nationwide in the United States (specifically New Jersey, Pennsylvania, and Virginia) and in Canada. The specific serial numbers involved are NU038A018, NU038A019, NU038A022, NU038A027, NU038A028, and NU038A029.

Healthcare facilities and users should stop using the affected endoscopes and contact Fujinon Inc for further instructions on the recall.

The recalled product

Product
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.
Manufacturer
Fujinon Inc
Category
Medical Device — Endoscope
Hazard
Affected units
12

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Related recalls

Same hazard · structural defect

See all →