HIGH

Olympus Bronchoscope Recalled Over Safety Instructions Update

Olympus Corporation of the Americas recalled 3,216 bronchoscope units on September 11, 2025. The recall affects 347 units in the U.S. and includes critical updates to instructions for use. Patients and healthcare providers must stop using the 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

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Product Details

The recall involves the OES Bronchoscope Olympus BF Type 1T60. A total of 347 units were distributed in the United States, with an additional 2,869 units distributed outside the U.S. The product is classified as Class I.

The Hazard

The recall addresses updates to the Instructions for Use (IFU) to clarify the safe and effective use of bronchoscopes in conjunction with laser, argon plasma coagulation, and high-frequency therapy equipment. Failure to adhere to updated instructions may pose risks during medical procedures.

Reported Incidents

There are no reported incidents, injuries, or deaths associated with this recall at this time. The company initiated the recall proactively to enhance user safety.

What to Do

Patients and healthcare providers should stop using the bronchoscope immediately. Follow the recall instructions provided by Olympus Corporation of the Americas or consult 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 specific recall instructions.

Key Facts

  • 347 units recalled in the U.S.
  • 2,869 units recalled outside the U.S.
  • Class I recall due to safety updates.
  • Immediate cessation of use required.

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
Model No. BF-1T60
UDI: 4953170339264
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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