HIGH

Olympus Recalls Bronchoscopes Due to Safety Concerns

Olympus Corporation recalled 1,070 EVIS EXERA II bronchoscopes on September 11, 2025. The recall addresses safety concerns regarding their use with laser and high-frequency therapy equipment. Healthcare providers should stop using these devices 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 II Bronchovideoscope Olympus BF Type P180. A total of 1,070 units are recalled in the U.S. and 2,180 units internationally. The devices were distributed nationwide.

The Hazard

The recall stems from additional instructions for use updates. These updates clarify the safe and effective use of bronchoscopes when combined with laser, argon plasma coagulation, and high-frequency therapy equipment.

Reported Incidents

No specific incidents, injuries, or deaths have been reported in connection with this recall. However, the risk associated with improper use necessitates immediate action.

What to Do

Stop using the affected bronchoscopes immediately. Patients and healthcare providers should follow the recall instructions provided by Olympus Corporation.

Contact Information

For further instructions, contact Olympus Corporation of the Americas. Visit their website or call customer service for assistance.

Key Facts

  • Recall date: September 11, 2025
  • Quantity: 1,070 units in the U.S.
  • Classification: Class I
  • High hazard level
  • Immediate action required

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Safety Assessment

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

Product Classification

Product TypeBronchoscopes
Sold At
Multiple Retailers

Product Details

Model Numbers
Model No. BF-P180
UDI: 4953170339288
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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