Olympus Corporation of the Americas has recalled 12,195 units of the Olympus EVIS EXERA III Duodenovideoscope (Model TJF-Q190V) due to a potential risk of microbial contamination. Surveillance data indicates that bacteria levels on the device may increase if manual cleaning is delayed for more than one hour after a procedure, specifically when a presoak is performed. While no injuries or infections have been reported to date, the manufacturer is taking this action to ensure devices are cleaned effectively between patient uses.
Microbial contamination can occur if manual cleaning is delayed beyond one hour after a procedure, which may lead to serious infections in patients who undergo subsequent medical procedures with the device.
Quantity: 12,195 units; Recall #: Z-1911-2025
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
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Sources: FDA iRES · Raw API Response
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