FUJINON ED-530XT — Class II medical device recall Z-3225-2017
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2017-10-04, distributed nationwide. An update to the design and labeling was implemented to help reduce patient risk associated with inadequate re
| Recall number | Z-3225-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fujifilm Medical Systems U.S.A., Inc., Wayne, NJ, United States |
| Recall initiated | 2017-07-21 |
| Classified | 2017-09-27 |
| Reported by FDA | 2017-10-04 |
| Terminated | 2018-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 362 units |
| Reason classes | labeling, packaging |
Product
FUJINON ED-530XT. This device is intended for the visualization of the duodenum and upper digestive tract, specifically for the observation, diagnosis, and endoscopic treatment of the esophagus, stomach, and duodenum.
Reason for recall
An update to the design and labeling was implemented to help reduce patient risk associated with inadequate reprocessing of the device. The action includes replacement of the forceps elevator mechanism, the O-ring seal, the distal end cap and issuance of a new Operation Manual.
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-3225-2017. 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.