HIGH

Olympus Bronchofiberscope Recalled Over Safety Concerns

Olympus Corporation of the Americas recalled the Bronchofiberscope Model No. BF-TE2 on September 11, 2025. The recall affects 5,287 units due to safety concerns when used with laser and high-frequency therapy equipment. Users should stop using the device immediately and contact Olympus for further 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 Bronchofiberscope Olympus BF Type TE2, with the UDI 4953170339998. The recall affects 1 unit in the U.S. and 5,286 units distributed internationally.

The Hazard

The recall stems from additional instructions for use (IFU) updates. These updates clarify safe practices when using the bronchoscopes in conjunction with laser and argon plasma coagulation equipment.

Reported Incidents

No specific incidents or injuries associated with the recall have been reported. The recall is precautionary based on updated safety information.

What to Do

Stop using the Bronchofiberscope immediately. Follow the recall instructions provided by Olympus Corporation. Contact your healthcare provider for further guidance.

Contact Information

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

Key Facts

  • Recall date: September 11, 2025
  • Quantity affected: 5,287 units
  • Device model: BF-TE2
  • UDI: 4953170339998
  • Safety classification: Class I

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Safety Assessment

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

Product Details

Model Numbers
Model No. BF-TE2
UDI: 4953170339998
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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