Olympus EVIS EXERA III Duodenovideoscope TJF-Q190V Contamination Risk
Olympus is recalling the EVIS EXERA III Duodenovideoscope Model TJF-Q190V due to post-market data showing higher microbial contamination when manual cleaning is delayed beyond one hour after patient use.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall of a high-risk device (endoscope) where post-market data indicates increased microbial contamination risk. No illnesses or injuries are reported in the source, but the hazard involves a pathogenic risk pathway (microbial contamination) that could lead to patient harm if not addressed, meeting the High severity threshold.
Plain-English summary
Olympus Corporation of the Americas is recalling the EVIS EXERA III Duodenovideoscope, Model Number TJF-Q190V, worldwide. Recent post-market surveillance data suggests a possible association of higher microbial contamination levels in these duodenoscopes when manual cleaning was delayed beyond one hour after patient procedures, particularly when a presoak was performed.
Approximately 12,195 units have been distributed in the United States and internationally to countries including Canada, Mexico, Brazil, Japan, Australia, and many others listed by Olympus. The device is identified by UDI-DI 04953170405563, and all serial numbers of the TJF-Q190V model are affected.
Healthcare facilities currently using this duodenoscope should review their cleaning protocols to ensure manual cleaning begins within one hour after each patient procedure. Customers should contact Olympus Corporation of the Americas for further guidance on proper cleaning procedures and any additional actions needed to reduce contamination risk.
The recalled product
- Product
- Olympus EVIS EXERA III Duodenovideoscope. Model Number: TJF-Q190V
- Manufacturer
- Olympus Corporation of the Americas
- Hazard
- microbial-contamination
- improper-cleaning
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04953170405563. Model Number: TJF-Q190V. All serial numbers.
Distribution
Distributed nationwide across the United States.
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