HIGH

Olympus Recalls EVIS EXERA III Bronchoscope Over Safety Concerns

Olympus Corporation of the Americas recalled 3,046 units of its EVIS EXERA III bronchoscope BF-P190 on September 11, 2025. The recall addresses safety concerns regarding the use of the bronchoscope with laser and high-frequency therapy equipment. Healthcare providers must stop using this device immediately.

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 recall involves the EVIS EXERA III bronchoscope, model BF-P190. It was distributed nationwide in the United States and includes 3,046 units. No pricing information is available.

The Hazard

The recall was initiated due to additional instructions for use (IFU) updates needed for safe and effective use with laser and argon plasma coagulation equipment. This situation poses a high hazard level.

Reported Incidents

As of now, there are no reported incidents or injuries related to this recall. The device's classification is Class I, indicating a high risk.

What to Do

Patients and healthcare providers should stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation or contact your healthcare provider for further guidance.

Contact Information

For more information, contact Olympus Corporation of the Americas. Visit their website at www.olympus.com or call their customer service.

Key Facts

  • Recall date: September 11, 2025
  • Distribution: US Nationwide
  • Quantity recalled: 3,046 units
  • High hazard level
  • Class I device
View Original Recall on FDA - Medical Devices

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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

Model Numbers
Model No. BF-P190
UDI: 4953170342110
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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