CLASS II Device recall · Reported 6 Nov 2013 · FDA Enforcement Report
Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide recalled
Fujinon is recalling Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic images of submucosal, distributed nationwide in the US. The recall was initiated on 31 Jul 2013 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0112-2014
- FDA event ID
- 66144
- Recalling firm
- Fujinon, Wayne, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 31 Jul 2013
- FDA classified
- 29 Oct 2013
- Reported
- 6 Nov 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Surgical Instruments
Timeline
| 31 Jul 2013 | Recall initiated by company | |
| 29 Oct 2013 | Classified by FDA | +90 days |
| 6 Nov 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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.
Where it was distributed
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Model Number EG-530UT2. Serial Numbers: NU038A018, NU038A019, NU038A022, NU038A027, NU038A028 and NU038A029
Where was it sold?
Worldwide distribution: US (nationwide) including states of: NJ, PA and VA; and country of Canada.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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