HIGH

Olympus Recalls Bronchovideoscope Over Safety Instructions Update

Olympus Corporation of the Americas recalled the Bronchovideoscope BF Type P150 on September 11, 2025. The recall affects 1,019 units distributed outside the U.S. This action follows updates to the instructions for use regarding safe operations with laser and high-frequency therapy equipment.

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
Unknown
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 Bronchovideoscope Olympus BF Type P150. Model numbers include BF-P150 and UDI 4953170308178. The product is not available in the U.S. market but has a distribution of 1,019 units internationally.

The Hazard

The recall addresses updates to the instructions for safe and effective use of the bronchovideoscope with laser, argon plasma coagulation, and high-frequency therapy equipment. Misuse can lead to serious complications during medical procedures.

Reported Incidents

There are no specific incidents reported in the recall notice. However, the recall is classified as Class I, indicating a high risk of serious injury or death.

What to Do

Patients and healthcare providers should stop using the Bronchovideoscope 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 https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=Z-0055-2026 for details.

Key Facts

  • Recall date: September 11, 2025
  • Distribution: 1,019 units OUS
  • Class I recall due to high risk
  • Stop using the device immediately

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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-P150
UDI: 4953170308178
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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