Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Updated Reprocessing Instructions
Olympus Corporation is recalling 431 BF-Q180-AC EVIS EXERA II Bronchovideoscopes to issue validated reprocessing instructions aligned with FDA 2015 guidance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 device recall involving reprocessing instructions with no reported illnesses or injuries. The update aligns with FDA guidance and applies to procedural labeling rather than a device defect.
Plain-English summary
Olympus Corporation of the Americas is recalling the BF-Q180-AC EVIS EXERA II Bronchovideoscope. The recall affects 431 units distributed domestically and globally, encompassing all serial numbers of this model.
The firm is issuing validated, new reprocessing instructions according to FDA 2015 guidance on reprocessing medical devices in health care settings.
The recalled product
- Product
- BF-Q180-AC EVIS EXERA II Bronchovideoscope, Model No. BF-Q180-AC
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Hazard
- Affected units
- 431
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)
- All serial numbers
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Olympus Corporation of the Americas 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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