FDA Medical Device Recalls (openFDA)
Fujifilm Medical Systems U.S.A., Inc.: 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.
- Recall number
- Z-0418-2016
- Recalling firm
- Fujifilm Medical Systems U.S.A., Inc.
- 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.
- Status
- Terminated
- Initiated
- 2015-08-31
- Posted
- not on file
- Terminated
- 2018-03-21
- Reason
- A precautionary measure because the Duodenoscopes have been redesigned to incorporate a closed elevator wire channel that facilitates reprocessing.
- Root cause
- Device Design
- Action
- FujiFilm mailed a Medical Device Recall Letter and Tracking/Verification Form dated August 31, 2015, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to check their inventory for affected product, if found, affected product should be removed from circulation and returned to Fugifilm. Customers were also asked to complete and return the enclosed tracking/verification form to Fujifilm Medical Systems USA, Inc., Endoscopy Division (FMSU-ESD), 10 High Point Drive, Wayne, NJ 07470 or via fax to 973-633-8818. Customers with questions were instructed to contact their Fujifilm sales representative. For questions regarding this recall call 973-686-2482
- Quantity
- 79 units (US) and 985 units (Internationally)
- Distribution
- US including CA, CO, FL, IA, IL, KS, LA, MD, MN, MO, NC, TN and WA and Internationally to Asian Pacific, EU, Latin America, and Japan.
- Lot, serial or model codes
- Model Number: ED-200XU: Serial Numbers: 6572042, 5511033 and H451107 Model Number: ED-200XT: Serial Number: 8681034 Model Number: ED-250XT: Serial Number: HD077A008 Model Number: ED-310XU: Serial Number: 8591013 Model Number: ED-420XL: Serial Numbers: 9711002, 2D071D016, 2D071D010, 2D071D029 and 2D071D026 Model Number: ED-410XT: Serial Numbers: 8691039, 8691034 and 7691022 Model Number: ED-410XU: Serial Numbers: 2D060D010, 2D060D003, 6602091 and 6602100 Model Number: ED-450XL: Serial Numbers: 6D075B023, 6D075B015, 1D075B029 and 6D075B020 Model Number: ED-450XT: Serial Numbers; 1D076A002, 1D076A011, 1D076A013, 1D076A043, 1D076A039, 6D076A020, 6D076A033, 6D076A039, 6D076A037, 6D076A030 and 6D076A051
- 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