Olympus Bronchovideoscope Recalled Due to Lodging Risk in Airway
Olympus is recalling Bronchovideoscope Model BF-XT190 units because the device diameter is too large, causing the endoscope to become lodged in endotracheal tube connectors.
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 Class II recall for a design defect that causes device lodging in a critical airway component. Although no injuries or hospitalizations are reported, the inherent risk of airway obstruction from a lodged endoscope during medical procedures qualifies this as a high-risk product where harm has not yet been reported.
Plain-English summary
Olympus Corporation of the Americas is recalling Bronchovideoscope Model BF-XT190 units distributed throughout the United States. The endoscope can become lodged in the endotracheal tube connector because the device diameter is too large.
Approximately 235 units were affected. The recalled equipment is identified by UDI-DI 04953170402470, and all serial numbers are included in this recall.
Healthcare facilities and medical professionals should immediately discontinue use of the affected Bronchovideoscope units. Contact Olympus Corporation of the Americas for information regarding replacement, repair, or return of the recalled devices.
The recalled product
- Product
- Olympus Bronchovideoscope, Models BF-XT190.
- Manufacturer
- Olympus Corporation of the Americas
- Category
- Medical Device — Endoscope
- Affected units
- 235
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: 04953170402470
- 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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