Agency classClass IIOur severity:High FDA (Devices)·Z-2496-2023·Announced 2023-09-06

Olympus Bronchovideoscope Models Recalled Due to Lodgement Risk in Connectors

Olympus is recalling 9,449 bronchovideoscope units nationwide due to complaints that the endoscope can become lodged in endotracheal tube connectors due to 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 a Class II FDA recall describing a risk-of-harm situation in which the endoscope can become lodged in critical airway connectors, but no illnesses or injuries have been reported.

Plain-English summary

Olympus Corporation of the Americas is recalling 9,449 units of four bronchovideoscope models (BF-1TH190, BF-H190, BF-Q170, and BF-Q190) distributed nationwide in the United States. The recall is being issued because the endoscope component can become lodged in endotracheal tube connectors due to the endoscope diameter being larger than the connector opening allows.

A bronchovideoscope lodged in an endotracheal tube connector could impede proper medical procedures and potentially compromise airway management during patient care. This medical device is used during respiratory procedures where proper fit and unrestricted access are essential to patient safety.

Healthcare providers and facilities using these models should immediately discontinue use and contact Olympus Corporation of the Americas for instructions on replacement or repair. The recall includes all serial numbers of the affected models, identified by specific Universal Device Identifier (UDI-DI) codes.

The recalled product

Product: Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190.
Manufacturer: Olympus Corporation of the Americas
Category: Medical Device — Endoscope
Hazard: device-lodgement
design-defect
Affected units: 9,449

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 (8)

UDI-DI: 04953170335181
04953170434778
04953170335174
04953170434754
04953170342912
04953170335198
04953170434792
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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