Fujifilm Medical Systems Duodenoscope — Class II medical device recall Z-0418-2016
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2015-12-23, distributed in CA, CO, FL, IA, IL, KS, LA, MD…. A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire c
| Recall number | Z-0418-2016 |
|---|---|
| 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 | 2015-08-31 |
| Classified | 2015-12-15 |
| Reported by FDA | 2015-12-23 |
| Terminated | 2018-03-21 |
| Distributed | CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN, WA |
| Countries outside the US | JP |
| Serial numbers | 1D075B029, 1D076A002, 1D076A011, 1D076A013, 1D076A039, 1D076A043, 2D060D003, 2D060D010, 2D071D010, 2D071D016, 2D071D026, 2D071D029, 5511033, 6572042, 6602091, 6602100, 6D075B015, 6D075B020, 6D075B023, 6D076A020, 6D076A030, 6D076A033, 6D076A037, 6D076A039, 6D076A051 and 8 more |
| Model numbers | ED-200XT, ED-200XU, ED-250XT, ED-310XU, ED-410XT, ED-410XU, ED-420XL, ED-450XL, ED-450XT |
Product
Fujifilm Medical Systems Duodenoscope, Model Numbers ED-200XU, ED-200XT, ED-250XT, ED-310XU, ED-420XL, ED-410XT, ED-410XU, ED-450XL, and ED-450XT. Medical endoscope for the duodenum and upper G.I. tract. Open elevator wire channel duodenoscopes.
Reason for recall
A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
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-0418-2016. 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.