Fujinon/Fujifilm Ultrasonic Endoscope Intended to provide ultrasonic… — Class II medical device recall Z-0112-2014
Terminated recall by Fujinon Inc, reported 2013-11-06, distributed nationwide. A limited number of endoscopes were shipped to FMSU-ESD with a manufacturing defect which included missing set
| Recall number | Z-0112-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujinon Inc, Wayne, NJ, United States |
| Recall initiated | 2013-07-31 |
| Classified | 2013-10-29 |
| Reported by FDA | 2013-11-06 |
| Terminated | 2014-03-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 12 units |
| Serial numbers | NU038A018, NU038A019, NU038A022, NU038A027, NU038A028, NU038A029 |
| Model numbers | EG-530UT2 |
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.
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0112-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.