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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
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 TypeBronchoscope
Sold At
Multiple Retailers
Product Details
Categories
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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