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
- Bronchoscope (Bronchovideoscope)
- Model numbers
- BF-1TH190
- 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-1TH190 is a flexible bronchovideoscope used by trained clinicians to visualize airways and perform navigation-based procedures.
Why This Is Dangerous
The recall addresses safety and effectiveness concerns related to updated IFU guidance for use with laser, APC and high-frequency therapy equipment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must implement updated protocols and training, which may delay procedures and affect scheduling until new guidance is adopted.
Practical Guidance
How to identify if yours is affected
- Verify device model BF-1TH190
- Confirm all serial numbers are affected
- Cross-check against FDA recall page (Z-0049-2026)
Where to find product info
Recall notices and device identifiers are available on the FDA recall page linked in the source data and Olympus communications.
What timeline to expect
4-8 weeks for refunds or replacements after submission of required documentation
If the manufacturer is unresponsive
- Escalate to hospital procurement leads
- Request written confirmation from Olympus
- Consider filing a consumer protection complaint if delays exceed standard timelines
How to prevent similar issues
- Verify IFU updates before procedures
- Ensure staff training reflects latest safety guidance
- Monitor for additional recall notices from Olympus or FDA
Documentation advice
Document all communications, keep copies of recall notices, UDI and model verification, and preserve receipts and shipment records for replacement devices
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Product Details
Model BF-1TH190; UDI 4953170434778; All Serial Numbers affected. US distribution: nationwide. International distribution: outside US. Quantity recalled: 4,297 US; 4,290 outside US. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 8,587 total units recalled
- 4,297 US; 4,290 outside US
- Model BF-1TH190; UDI 4953170434778
- All Serial Numbers affected
- Recall status ACTIVE as of 2025-10-22
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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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