Agency classClass IIOur severity:High FDA (Devices)·Z-2494-2023·Announced 2023-09-06

Olympus Bronchovideoscope Recall Due to Device Lodging Risk

Olympus is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F because the device diameter is too large and can become lodged in the endotracheal tube connector. Healthcare facilities should discontinue use and contact Olympus.

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 a Class II medical device recall involving a mechanical defect that creates significant risk of device entrapment during critical airway procedures. Although no injuries or illnesses are reported in the source text, the defect affects core functionality of an essential respiratory device, warranting a High severity rating per the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling Bronchovideoscope Models BF-UC180F and BF-UC190F. These medical devices are used in bronchoscopy procedures to visualize and access the patient's airways. Approximately 4,115 units have been distributed nationwide in the United States.

The recall was initiated following complaints that the endoscope can become lodged in the endotracheal tube connector due to the device diameter being too large. If lodged, the endoscope may not be removable and could interfere with airway management during patient procedures.

Healthcare facilities and clinicians currently using these bronchovideoscope models should discontinue use immediately. Contact Olympus Corporation of the Americas for instructions on device return, repair, or replacement. The affected device UDI-DI numbers are 04953170356360 and 04953170399831; all serial numbers are included.

The recalled product

Product: Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Respiratory / Endoscopy
Hazard: mechanical-defect
entrapment
airway-risk
Affected units: 4,115

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: 04953170356360 and 04953170399831
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.

See all 15 products in this recall →

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