FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Recall number
- Z-2269-2018
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus JF-140F duodenoscopes (Model NumberJF-140F)
- Status
- Terminated
- Initiated
- 2018-05-11
- Posted
- not on file
- Terminated
- 2020-05-05
- Reason
- Issuance of validated, new reprocessing procedures. This corrective action is being undertaken as a result of ongoing manufacturer and FDA activities relating to reported patient infections associated with duodenoscopes. The new cleaning procedure requires additional recess flushing and forceps elevator raising/lowering steps during precleaning, manual cleaning and manual disinfection.
- Root cause
- Under Investigation by firm
- Action
- Firm is extending recall to the user level Letters will be sent on May, 11, 2018 via overnight mail to customers Follow-up phone calls to consignees to offer training on new reprocessing instructions No action can be taken with hospitals that are no longer in business
- Quantity
- 994
- Distribution
- Nationwide
- Lot, serial or model codes
- All
- 510(k) numbers
- ["K853585"]
- PMA numbers
- not on file
- Product code
- FET
- Firm FEI
- 2429304
- Firm city
- Center Valley
- Firm state
- PA
- 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