FDA Medical Device Recalls (openFDA)
Olympus Corporation of the Americas: EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
- Recall number
- Z-2467-2023
- Recalling firm
- Olympus Corporation of the Americas
- Product
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
- Status
- Open, Classified
- Initiated
- 2023-07-27
- Posted
- 2023-08-28
- Terminated
- not on file
- Reason
- Recent reports of patient infection.
- Root cause
- Under Investigation by firm
- Action
- Consignees were sent an Urgent Medical Corrective Action notification dated 7/27/2023. This action is being initiated due to the firm becoming aware of and FDA inquiring about recent reports of infections and positive cultures. Olympus is reminding users to closely follow reprocessing instructions, including periodic inspections by Olympus Service, and informing users about an updated manual intended to improve comprehension of existing reprocessing steps. Additional enhancements to the manual include the use of reprocessing timelines and simplified text/visualization techniques. The manual is available on the customer web portal and paper copies, along with wall charts, are available to be mailed to your facility. The notification also emphasises the required inspection of the forceps elevator mechanism, to be performed once a year or every 100 reprocessing cycles, and encourages consignees to consider incorporating voluntary routine microbiologic surveillance of endoscops as part of their quality improvement/assurance efforts. Consignees are asked to complete and return the provided response form to Sedgwick via email at ollympus7521@sedgwick.com or by fax to 888-208-4588. Questions can be directed by phone to 866-912-9552. Customers can also contact Ashley Mitch at Olympus by phone at 484-553-1029 or by email at Ashley.Mitch@olympus.com with any additional concerns.
- Quantity
- 6,426 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.
- 510(k) numbers
- ["K193182","K202661","K220587"]
- PMA numbers
- not on file
- Product code
- FDT
- 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