Bronchovideoscope Manual Cleaning Updated: Reusable Brushes No Longer Approved
Olympus has updated cleaning instructions for the EVIS EXERA III Bronchovideoscope. Reusable brushes are no longer approved for manual cleaning; only single-use brushes should be used.
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: FDA Class II recall with updated instructions for use but no reported illnesses, injuries, or deaths. The recall consists of removing reusable brushes from approved manual cleaning procedures, representing a procedural correction rather than an imminent danger.
Plain-English summary
Olympus has issued an updated instruction for use regarding cleaning procedures for the Model BF-XP190 EVIS EXERA III Bronchovideoscope. The update removes reusable cleaning brushes from approved manual cleaning methods. Single-use brushes remain compatible and should be used instead.
The affected bronchovideoscopes have been distributed nationwide throughout the United States. All serial numbers of this device are subject to this instruction update.
Olympus has classified this as a Class II recall. No illnesses or injuries have been reported in connection with this issue. Users of the EVIS EXERA III should follow the updated cleaning instructions to ensure proper equipment maintenance and procedure compliance.
Healthcare providers and facilities using this device should reference the updated instructions for use available from Olympus.
The recalled product
- Product
- Model No. BF-XP190, EVIS EXERA III Bronchovideoscope
- Manufacturer
- Shirakawa Olympus Co., Ltd.
- Category
- Medical Device — Endoscope
- Hazard
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: 04953170342134 All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 9 recalled by Shirakawa Olympus Co., Ltd. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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