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
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 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
- Bronchovideoscope
- Model numbers
- BF-Q190, UDI: 4953170434792, 4953170335198, All Serial No.
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
September 11, 2025
Reported by FDA DEVICE
October 22, 2025
RecallRadar source check
April 18, 2026
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 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
- Verify device is BF-Q190
- Confirm serial number status (All Serial No.)
- 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
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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
- All Serial No.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
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