EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V recallZ-2467-2023 · Olympus Corporation of the Americas · initiated Jul 27, 2023
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Olympus Corporation of the Americas or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Recent reports of patient infection.
FDA root cause category: Under Investigation by firm
What the company is doing
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 [email protected] 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 [email protected] with any additional concerns.
Recall details
- Recall number
- Z-2467-2023
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2023
- Posted by the FDA
- Aug 28, 2023
- Recalling firm
- Olympus Corporation of the Americas
- Quantity
- 6,426 units
- Product code
- FDT
- FDA submissions
- K193182, K202661, K220587
- Distribution
- US Nationwide distribution.
Product description
EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V
Code information (models, lots, serial numbers)
Model No. TJF-Q190V; UDI-DI: 04953170405563; All Serial No.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190VOlympus Medical Systems Corp. · Duodenoscope and accessories, flexible/rigid4 recalls10 deaths4,900 reports
Product lines
Other devices under the same FDA submission
2 devices cleared under K193182, K202661, K220587 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- SINGLE USE DISTAL COVER MAJ-2315Olympus Medical Systems Corp. · Accessories, Cleaning, For Endoscope2 recalls294 reports
- CONNECTING TUBE MAJ-2358Olympus Medical Systems Corp. · Duodenoscope And Accessories, Flexible/Rigid2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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