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Olympus BF-Q180-AC Bronchoscope Recall Due to Safety Issues - Stop Using Now

Olympus recalled 395 EVIS EXERA II bronchoscopes after updates revealed safety concerns. The bronchoscope's instructions for use with laser and coagulation equipment lacked clarity, posing high risks during procedures. Patients and healthcare providers must stop using this device and follow recall instructions immediately.

Official notice
Olympus Corporation of the AmericasHealth & Personal CareMedical DevicesModel No. BF-Q180-ACUDI: 4953170340086All Serial No.

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 11, 2025
Status
ACTIVE
Severity
8/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Olympus Corporation of the Americas
Product type
Bronchoscope
Model numbers
Model No. BF-Q180-AC, UDI: 4953170340086, All Serial No.
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 11, 2025

  2. Reported by FDA DEVICE

    October 22, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The Olympus BF-Q180-AC bronchoscope is a medical device used for visual examination and therapy within the bronchial tubes. Medical professionals commonly use it to assist patients with respiratory issues during procedures.

Why This Is Dangerous

The latest updates to the use instructions may lead to improper use with laser or coagulation therapy equipment, resulting in complications that could endanger patient safety.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

The recall requires immediate action to cease use, affecting both healthcare providers and patients relying on its application in procedures.

Practical Guidance

How to identify if yours is affected

  1. Verify the model number and UDI to confirm if your bronchoscope is recalled.
  2. Check with your healthcare provider to see if your device was used in related procedures.
  3. Consult the recall notice for specific instructions on how to proceed.

Where to find product info

Model number and UDI are typically found on the device's labeling or packaging.

What timeline to expect

Expect response and instructions from Olympus Corporation within a couple of weeks after reporting the issue.

If the manufacturer is unresponsive

  • Document all communication attempts with Olympus.
  • Contact the FDA for further guidance if needed.
  • Consider filing a complaint regarding the non-response.

How to prevent similar issues

  • Always check for device recalls before using medical equipment.
  • Review any updates or instructions provided by the manufacturer regularly.
  • Consult with a healthcare professional about the proper use of medical devices.

Documentation advice

Keep copies of all communications regarding this recall, including emails and notes of phone calls.

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Product Details

Model No. BF-Q180-AC. UDI: 4953170340086. 395 units recalled in the US; 165 units distributed outside the US.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 395 units recalled in the US, 165 units distributed outside the US
  • Model No. BF-Q180-AC
  • Immediate cessation of use is required
  • No reported injuries or incidents

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 Classification

Product Details

Model Numbers
Model No. BF-Q180-AC
UDI: 4953170340086
All Serial No.
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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