HIGH

Olympus Recalls Bronchoscope Over Safety Instructions Clarification

Olympus Corporation recalled 619 bronchoscope units on September 11, 2025. The recall affects the EVIS EXERA b BRONCHOVIDEOSCOPE BF-XT190 due to additional instructions for safe use. Healthcare providers and patients 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

Product Details

The recall involves the EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190. A total of 361 units were distributed in the United States, while 258 units were distributed outside the U.S. The device is part of the medical equipment range.

The Hazard

The recall addresses the need for updated instructions for use (IFU) to clarify the effective use of bronchoscope models when paired with laser and high-frequency therapy equipment. This clarification aims to prevent potential misuse and ensure patient safety.

Reported Incidents

There are no reported incidents or injuries directly linked to this recall. However, the high-risk classification indicates that improper usage could lead to serious complications.

What to Do

Patients and healthcare providers should stop using the device immediately. They should follow the recall instructions provided by Olympus Corporation of the Americas.

Contact Information

For further instructions, contact Olympus Corporation of the Americas at [insert phone number]. Visit their website for more details.

Key Facts

  • Recall date: September 11, 2025
  • Total units recalled: 619
  • Classification: Class I
  • Device model: BF-XT190
  • High hazard level
View Original Recall on FDA - Medical Devices

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Safety Assessment

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

Product Classification

Product TypeBronchoscope
Sold At
Multiple Retailers

Product Details

Model Numbers
Model No. BF-XT190
UDI: 4953170402470
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Source Agency
FDA - Medical Devices
Recall Status
ACTIVE

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