Olympus Bronchovideoscope Recalled for Risk of Lodging in Airway Connector
Olympus Corporation is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 due to a dimensional defect that can cause the endoscope to become lodged in an endotracheal tube connector.
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: FDA classified this as a Class II recall. Although the dimensional defect poses a risk of device lodging during medical procedures, no injuries or hospitalizations have been reported in the source material. This meets the rubric criterion for High severity: a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling 1,004 units of the Bronchovideoscope Model BF-3C160 nationwide. This endoscope is used in bronchoscopy procedures for airway examination.
A complaint has been received that the endoscope model can become lodged in an endotracheal tube connector during use. The defect is attributed to the endoscope having an outside diameter that is too large. An endotracheal tube connector is a standard component used in airway management and anesthesia procedures.
The affected units are identified by UDI-DI 04953170340031 and 04953170063039, with all serial numbers of Model BF-3C160 included in this recall.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-3C160.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscopy
- Affected units
- 1,004
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: 04953170340031 & 04953170063039
- 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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