The Recall Desk
HighFDA (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.

What this means for you

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
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 →

Related recalls

Same manufacturer · Olympus Corporation of the Americas

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Same hazard · device lodgement

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