FDA updates cleaning instructions for EVIS EXERA III bronchovideoscope
Shirakawa Olympus has updated cleaning instructions for the EVIS EXERA III bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; single-use brushes remain compatible.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving an update to cleaning instructions. No illnesses, injuries, or deaths have been reported. The change is precautionary, removing a previously approved cleaning method to ensure proper device sterilization.
Plain-English summary
Shirakawa Olympus Co., Ltd. has updated the instructions for use for the Model No. BF-P190, EVIS EXERA III bronchovideoscope, removing reusable cleaning brushes from the approved manual cleaning procedures. Single-use brushes remain compatible with the device.
The EVIS EXERA III bronchovideoscope is used in medical settings to visualize the respiratory tract during diagnostic and therapeutic procedures. A total of 2,600 units have been distributed in the United States, with 3,214 units distributed outside the US.
Healthcare providers and facilities using this device should immediately update their cleaning protocols to use only single-use brushes for manual cleaning. Proper adherence to the updated cleaning instructions is essential to ensure the device is adequately cleaned and prevent potential cross-contamination between patients.
The recalled product
- Product
- Model No. BF-P190, EVIS EXERA III Bronchovideoscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Hazard
- inadequate-cleaning
- cross-contamination
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: 04953170342110 All serial numbers
Distribution
Distributed nationwide across the United States.
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