FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- Recall number
- Z-1007-2019
- Recalling firm
- Olympus Corporation of the Americas
- Product
- Olympus GF-UCT180 Ultrasound Gastrovideoscope - Product Usage: These endoscopes are intended for use in endoscopic diagnosis and treatment within the gastrointestinal tract.
- Status
- Terminated
- Initiated
- 2018-12-17
- Posted
- not on file
- Terminated
- 2020-11-18
- Reason
- The adhesive used in the repair of the endoscope was incorrectly prepared. It is unknown what affect the nonconforming adhesive mixture would have on the durability or effectiveness of the gluing operation for the endoscope repair.
- Root cause
- Under Investigation by firm
- Action
- Customers were contacted via telephone on 12/17/18. Customers were also sent notification letters on 1/2/19.
- Quantity
- 1
- Distribution
- US Nationwide distribution in the states of CT, IL, MN, MO, and NC.
- Lot, serial or model codes
- Serial Number 7621683
- 510(k) numbers
- ["K093395"]
- PMA numbers
- not on file
- Product code
- IYN
- 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