HIGH

Olympus Bronchofiberscope Recalled Due to Safety Concerns

Olympus Corporation of the Americas recalled 1,007 bronchofiberscopes on September 11, 2025, due to safety concerns related to their use with laser and high-frequency therapy equipment. The recall affects devices distributed nationwide in the U.S. and involves additional instructions for safe use.

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 recall involves the OES Bronchofiberscope Olympus BF Type P60, Model No. BF-P60. A total of 1,007 units are recalled in the U.S., with an additional 5,443 units affected worldwide. The devices were distributed nationwide.

The Hazard

The recall addresses safety concerns when using bronchoscopes in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. The updates clarify instructions for effective and safe use.

Reported Incidents

No specific incidents or injuries have been reported related to this recall. The recall is classified as Class I, indicating a high hazard level.

What to Do

Stop using the device immediately. Healthcare providers and patients should follow the manufacturer's recall instructions. Contact Olympus Corporation of the Americas for further guidance.

Contact Information

For more information, contact Olympus Corporation of the Americas. Visit their website or call for additional assistance.

Key Facts

  • Recall date: September 11, 2025
  • Quantity recalled: 1,007 units in the U.S.
  • Classification: Class I hazard
  • Contact Olympus for further instructions

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Safety Assessment

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

Product Classification

Product TypeBronchofiberscope
Sold At
Multiple Retailers

Product Details

Model Numbers
Model No. BF-P60
UDI: 4953170339196
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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