Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Olympus
- 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
- Product type
- Bronchovideoscope
- Model numbers
- BF-H1100, BF-H1100 UDI 4953170424229
- 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
Bronchovideoscopes are flexible endoscopes used during bronchoscopy to examine the airways and airways passages.
Why This Is Dangerous
The updated IFU provides guidance on safe and effective use when used with laser, APC, and high-frequency therapy equipment.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Healthcare facilities should review the updated IFU guidance and ensure staff are trained on compatible equipment use.
Practical Guidance
How to identify if yours is affected
- Identify BF-H1100 by model label on the device.
- Note that all serial numbers are affected.
- Review the recall notice for instructions.
Where to find product info
Label on device, packaging, IFU, and FDA recall page.
What timeline to expect
4-8 weeks for remedy processing if applicable; follow manufacturer instructions in the meantime.
If the manufacturer is unresponsive
- File a complaint with the FDA recall program if the manufacturer is unresponsive.
- Contact your healthcare provider for interim guidance.
How to prevent similar issues
- Stay updated on IFU changes when using bronchoscopes with adjunct therapies.
- Ensure staff are trained on updated safety guidelines.
- Verify compatibility with laser, APC, HF equipment before use.
Documentation advice
Keep recall notices, device labels, UDI, and all correspondence.
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Product Details
Model No.: BF-H1100; UDI: 4953170424229; Serial numbers: All Serial No.; Sold at: US nationwide distribution; 1,867 units overseas; Recall date: 2025-09-11; Status: Active
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 1,867 units recalled overseas
- Model BF-H1100; UDI 4953170424229
- Active recall; Hazard Level HIGH
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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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