FDA Device recall Z-1863-2016
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
- FDA Device
- Class II
- terminated
- Published 2016-06-08
On 2016-06-08 the FDA classified a Class II recall of Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage by Fujifilm Medical Systems U, citing this correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1863-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-12-23 |
| Published | 2016-06-08 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Fujifilm Medical Systems U |
| Distribution | US |
Product
Endoscope ED-450XT5 Operation Manual: Cleaning, Disinfection and Storage
Reason
This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
Identifiers
| code_info | All distribution dates :3/2003-4/2016 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1863-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.