Endoscope ED-250XL5 Operations Manual: Cleaning — Class II medical device recall Z-1861-2016
Terminated recall by Fujifilm Medical Systems U.S.A., Inc., reported 2016-06-08, distributed nationwide. This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for E
| Recall number | Z-1861-2016 |
|---|---|
| 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 | 2015-12-23 |
| Classified | 2016-05-31 |
| Reported by FDA | 2016-06-08 |
| Terminated | 2018-01-18 |
| Distributed | Nationwide (US) |
| Quantity | 98 units |
| Reason classes | microbial contamination |
Product
Endoscope ED-250XL5 Operations Manual: Cleaning, Disinfection
Reason for recall
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (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-1861-2016. 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.