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
- Model numbers
- BF-XT160, UDI: 4953170340147
- 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 Olympus BF-XT160 is a bronchoscope used in medical procedures to examine the airways and lungs. Medical professionals rely on it for diagnosing conditions and performing therapeutic interventions during bronchoscopies.
Why This Is Dangerous
This bronchoscope presents risks when used with certain therapies such as laser or high-frequency energy. Additional instructions highlight safe practices to prevent dangerous situations during medical procedures.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall affects healthcare providers and patients who rely on this bronchoscope for medical care, presenting potential safety hazards if not addressed promptly.
Practical Guidance
How to identify if yours is affected
- Locate the model number, BF-XT160, and UDI: 4953170340147 on the bronchoscope.
- Check any accompanying documentation for recall information.
- Verify with your healthcare provider whether your device is affected.
Where to find product info
Model numbers and UDI codes are typically found on the bronchoscope's handle or packaging labels.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements after submission.
If the manufacturer is unresponsive
- Document your attempts to contact Olympus, including dates and content of communication.
- Reach out to the FDA or relevant consumer protection agency if you receive no response.
How to prevent similar issues
- Always verify product safety certifications and compliance with medical regulations before use.
- Follow updated guidelines and instructions for specific medical devices.
- Stay informed about any recalls or safety announcements from manufacturers.
Documentation advice
Keep records of the recall notice, correspondence with Olympus, and any doctor visits related to the bronchoscope's use.
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Product Details
Brand: Olympus Corporation of the Americas Model: BF-XT160 UDI: 4953170340147 Quantity: 262 units in the US, 558 units OUS Distribution: US Nationwide Distribution
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 262 units recalled in the US
- 558 units recalled outside the US
- High hazard risk with laser therapy
- Recall initiated on September 11, 2025
- Contact Olympus for further instructions
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