HIGH

Olympus Recalls Bronchoscope Over Potential Safety Risks

Olympus Corporation of the Americas recalled 916 units of the EVIS EXERA III Bronchoscope BF-Q190 on September 11, 2025. The recall addresses safety concerns related to its use with laser and high-frequency therapy equipment. Healthcare providers must stop using the device immediately and follow recall instructions.

Quick Facts at a Glance

Recall Date
September 11, 2025
Hazard Level
HIGH
Brand
Olympus Corporation of the Americas
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Additional IFU updates to provide further clarification on safe and effective use of bronchoscopes when used in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Olympus Corporation of the Americas or your healthcare provider for instructions

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Product Details

The recalled product is the EVIS EXERA III Bronchoscope, model BF-Q190. It was distributed nationwide in the U.S. and there are 1,402 units recalled internationally. No pricing information was available.

The Hazard

The recall stems from additional updates to the Instructions for Use (IFU) relating to the safe and effective use of bronchoscopes with laser, argon plasma coagulation, and high-frequency therapy equipment. The potential for misuse could lead to serious health risks.

Reported Incidents

As of the recall date, there were no reported incidents, injuries, or deaths associated with this product. The high hazard level indicates significant concern, prompting the recall.

What to Do

Stop using the bronchoscope immediately. Contact Olympus Corporation of the Americas or your healthcare provider for further instructions.

Contact Information

For more information, contact Olympus Corporation of the Americas at their official website or customer service.

Key Facts

  • Recall affects 916 units in the U.S.
  • Additional IFU updates for safety clarification
  • Contact healthcare provider for further instructions.
  • High hazard level indicates significant concern.

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model No. BF-Q190
UDI: 4953170434792
4953170335198
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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