HIGH

Olympus EVIS EXERA III BF-Q190 Bronchovideoscope Recall Expands in 2025 for IFU Updates

Olympus Corporation of the Americas recalled 916 BF-Q190 bronchovideoscopes in the United States and 1,402 outside the US. The recall seeks to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Stop using the device immediately and follow the manufacturer’s recall guidance.

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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About This Product

The EVIS EXERA III BF-Q190 is a bronchovideoscope used during bronchoscopy to visualize airways. It is part of Olympus’ EVIS EXERA III platform.

Why This Is Dangerous

The recall updates the IFU to clarify safe use when combined with laser, APC and high-frequency therapy equipment, aiming to prevent improper operation.

Industry Context

This recall is not described as part of a broader industry pattern in the available notice.

Real-World Impact

The recall requires stopping use of the device until guidance is provided. The impact is operational for healthcare providers and patients awaiting alternate guidance.

Practical Guidance

How to identify if yours is affected

  1. Verify device is BF-Q190
  2. Check UDI codes 4953170434792 or 4953170335198
  3. Confirm serial number status (All Serial No.)
  4. Consult the official recall notice for instructions

Where to find product info

FDA enforcement page for recall Z-0063-2026 and Olympus recall communications

What timeline to expect

Remedy timeline not specified in the recall notice

If the manufacturer is unresponsive

  • Contact Olympus Corporation of the Americas for instructions
  • File a complaint with the FDA if you receive no response
  • Consult your healthcare facility's risk management team

How to prevent similar issues

  • Verify IFU for any device used with laser, APC, or HF therapy equipment
  • Confirm compatibility before procedures
  • Follow all manufacturer safety updates and regulatory notices
  • Maintain documentation of all recall communications

Documentation advice

Keep recall notices, model numbers, UDI codes, serial numbers, and all correspondence with the manufacturer and healthcare providers

Product Details

Model numbers: BF-Q190. Sold across US nationwide distribution; 1,402 units outside the US. Sold since: Not specified. Price: Not disclosed.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 916 US units recalled
  • 1,402 non-US units recalled
  • Model BF-Q190
  • UDI 4953170434792
  • UDI 4953170335198
  • All Serial No.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

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

Product Details

Model Numbers
BF-Q190
UDI: 4953170434792
4953170335198
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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