Olympus Bronchovideoscope Model BF-Q180-AC Recalled for Lodging Risk
Olympus Corporation is recalling 416 units of the Bronchovideoscope Model BF-Q180-AC nationwide because the endoscope can become lodged in the endotracheal tube connector due to an oversized diameter.
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 3/5 (High).
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: This is an FDA Class II recall for a mechanical defect where the endoscope can become lodged in the endotracheal tube connector. No injuries have been reported to date. It qualifies as High (Score 3) under the criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 416 units of the Olympus Bronchovideoscope Model BF-Q180-AC distributed nationwide. The company initiated this recall following a complaint that the endoscope model can become lodged in the endotracheal tube connector because the endoscope's diameter is larger than intended.
The recalled units are identified by UDI-DI 04953170340086. All serial numbers of the Olympus Bronchovideoscope Model BF-Q180-AC are affected.
The recalled product
- Product
- Olympus Bronchovideoscope, Model BF-Q180-AC
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device
- Affected units
- 416
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 (2)
- UDI-DI: 04953170340086
- All Serial Numbers.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 15 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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