Fujifilm Medical Endoscope for the duodenum and upper G — Class II medical device recall Z-2778-2015
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2015-09-23. The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the us
| Recall number | Z-2778-2015 |
|---|---|
| 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 | 2015-06-30 |
| Classified | 2015-09-17 |
| Reported by FDA | 2015-09-23 |
| Terminated | 2017-05-25 |
| Countries outside the US | CA |
| Quantity | 256 units |
| Model numbers | 202B1237681, 202B1237697D, 202B1260196A, 202B1260211A, ED-450XL5 |
Product
Fujifilm Medical Endoscope for the duodenum and upper G.I. tract. ED-530XT, ED-250XT5, ED-250XL5, ED-450XT5, and ED-450XL5 Endoscope Operation Manuals.
Reason for recall
The suction button on the ED-530XT endoscope may become lodged (stuck) in the active position following the use of x-ray contrast agents during ERCP procedures.
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-2778-2015. 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.