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
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL, PREGNANT, PREGNANT
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
- Model numbers
- BF-1TH1100, BF-1TH1100
- Sold at
- Unknown
- 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 used by healthcare professionals to view airways during bronchoscopy. They enable diagnosis and treatment of lung conditions.
Why This Is Dangerous
IFU updates are to clarify safe use when paired with energy devices like lasers and argon plasma coagulation. Misuse could lead to improper operation or patient risk.
Industry Context
This recall is not described as part of a broader industry pattern in the provided data.
Real-World Impact
Immediate halt in use; reliance on updated IFU to ensure safe operation in complex procedures.
Practical Guidance
How to identify if yours is affected
- Verify model BF-1TH1100 and UDI 4953170424199
- Confirm serial numbers against manufacturer records
- Review latest FDA recall page for updated IFU
Where to find product info
FDA recall page and Olympus customer support for product identifiers and instructions
What timeline to expect
Remedy processing times vary; follow official instructions for timelines
If the manufacturer is unresponsive
- Document all communications
- Escalate to hospital risk management or regulatory bodies if needed
- Consider contacting consumer protection agencies if manufacturer is nonresponsive
How to prevent similar issues
- Ensure bronchoscopy equipment is always used with the latest updated IFU
- Verify compatibility with laser and coagulation devices before use
- Attend required training on energy-device assisted bronchoscopy
- Keep updated recall communications from the manufacturer
- Document all device checks and procedure notes
Documentation advice
Keep recall notice, model and UDI details, communications with manufacturer, and any updated IFU for records
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Product Details
Model No. BF-1TH1100. UDI: 4953170424199. All Serial No. US distribution not specified; 1,913 units in outside U.S. distribution. Sold nationwide in the U.S.; 0 units in the U.S. currently recalled.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- 1,913 units outside the U.S.
- 0 units in U.S. currently recalled
- Active recall as of 2025-09-11
- Hazard level: HIGH
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Safety Guide
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