FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
- Recall number
- Z-1862-2016
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- Product
- Endoscope ED-250XT5 Operations Manual: Cleaning Disinfection and Storage
- Status
- Terminated
- Initiated
- 2015-12-23
- Posted
- not on file
- Terminated
- 2018-01-18
- Reason
- This correction is in response to publicized reports of multi-drug resistant bacteria on endoscopes used for Endoscopic Retrograde Cholangiopancreatogram (ERCP) procedures.
- Root cause
- Other
- Action
- Fujifilm issued a urgent field correction/Tracking/Verification form on 12/23/2015.
- Quantity
- 882 units
- Distribution
- Nationwide Distribution.
- Lot, serial or model codes
- All distribution dates :3/2003-4/2016
- 510(k) numbers
- ["K944759"]
- PMA numbers
- not on file
- Product code
- FDT
- Firm FEI
- 2431293
- Firm city
- Wayne
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28