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-1T60
- 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
Bronchoscopes are used by clinicians to view and treat the airways. The BF-1T60 is used in bronchoscopic procedures often with adjunct energy devices.
Why This Is Dangerous
The updated IFU provides guidance on safe and effective use when the device is used with laser, APC, and high-frequency therapy equipment. Misuse could lead to patient harm.
Industry Context
This recall is not described as part of a broader industry pattern in the notice.
Real-World Impact
Clinicians must verify procedures and ensure adherence to the updated IFU to mitigate patient risk during energy-device-assisted bronchoscopies.
Practical Guidance
How to identify if yours is affected
- Verify model BF-1T60 and UDI 4953170339264 on the device label and packaging.
- Check serial numbers; note that all serial numbers are affected.
- Review the updated IFU for safe use with laser, APC and HF devices.
Where to find product info
Manufacturer recall notices and the FDA enforcement page; device labeling and IFU updates from Olympus.
What timeline to expect
Refunds or replacements, if offered, may take weeks to months depending on the program.
If the manufacturer is unresponsive
- Escalate to hospital risk management or the device safety office.
- File a formal complaint with the manufacturer if no response is received within a reasonable timeframe.
How to prevent similar issues
- Ensure all staff are trained on the updated IFU.
- Avoid using the bronchoscope with energy devices unless the updated instructions are followed.
- Maintain documentation of recall communications and training.
Documentation advice
Keep copies of recall notices, correspondence with the manufacturer, and any inventory adjustments.
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Product Details
Model No. BF-1T60 UDI: 4953170339264 Serial numbers: All Serial No. Sold in: US Nationwide; International distribution Sold from: Unknown Price: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3,216 total units recalled (347 US; 2,869 outside the US)
- Model BF-1T60, UDI 4953170339264
- All Serial Numbers affected
- US Nationwide and international distribution
- Recall date 2025-09-11; status ACTIVE
- Hazard level HIGH; no reported injuries
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Safety Guide
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