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
- Bronchofiberscope
- Model numbers
- BF-TE2, UDI 4953170339998, 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 BF-TE2 bronchofiberscope is a flexible endoscope used for bronchoscopy to visualize airways. It is designed for procedures potentially used alongside laser, APC and high-frequency therapy equipment.
Why This Is Dangerous
The recall updates the IFU to clarify safe and effective use with adjacent equipment. Misuse may lead to harm during procedures that involve lasers or energy devices.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Hospitals and clinics must review the updated IFU, train staff, and halt use of affected devices until guidance is followed. Consumers may experience procedural delays while guidance is updated.
Practical Guidance
How to identify if yours is affected
- Confirm device model BF-TE2.
- Note that all serial numbers are affected.
Where to find product info
Recall notices on FDA enforcement page and Olympus website; device label may reference updated IFU.
What timeline to expect
No specific timeline published for refunds or replacements. Follow manufacturer instructions. Resolution timelines for medical device recalls vary by
If the manufacturer is unresponsive
- File a reported concern with the FDA CDRH
- Engage hospital risk management and document all communications
- Consider contacting legal counsel if no adequate response after a reasonable period
How to prevent similar issues
- Ensure staff are trained on updated IFU for bronchoscopes
- Verify IFUs before procedures using energy devices
- Maintain a proactive device recall tracking process
- Verify future suppliers provide updated safety instructions
Documentation advice
Keep a copy of the recall notice, correspondence with the manufacturer, and records of any device use involving lasers or energy devices.
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Product Details
Model No.: BF-TE2. UDI: 4953170339998. All Serial No. units affected. Sold in the United States and internationally. Quantity: 1 unit US; 5,286 units outside the US. Distribution: US Nationwide Distribution. Price: Unknown.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- BF-TE2 model is affected
- All serial numbers affected
- US unit count 1; overseas units 5,286
- Recall status ACTIVE
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Safety Guide
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