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-1T150
- 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 medical devices used to inspect airways and perform procedures. The BF-1T150 is a model in Olympus’ bronchoscope lineup intended for diagnostic and therapeutic use by trained clinicians.
Why This Is Dangerous
The recall updates the IFU to clarify safe and effective use when the bronchoscope is used with laser, APC and high-frequency therapy equipment, reducing the potential for misuse during procedures.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics using these devices with adjunctive therapy equipment should review and implement updated instructions. No injuries were reported in the recall data available.
Practical Guidance
How to identify if yours is affected
- Verify model number BF-1T150 on the device label.
- Check UDI 4953170308185 on the device packaging or label.
- Note that all serial numbers are affected.
- Cross-check the FDA recall reference Z-0045-2026.
Where to find product info
Identifiers appear on the bronchoscope label and packaging. The FDA recall page provides official guidance.
What timeline to expect
Recall actions involve updating IFU and provider communications. No refunds are noted; follow manufacturer instructions. Timelines will be issued by,,
If the manufacturer is unresponsive
- Escalate to FDA/Regulatory authorities if the manufacturer is unresponsive.
- Document all communications and actions taken.
How to prevent similar issues
- Ensure you are using the updated IFU with all applicable equipment.
- Provide staff training on safe use with laser, APC and HF devices.
- Establish a procedure to verify device documentation at point of care.
Documentation advice
Keep a copy of the recall notice, model number, UDI, serial numbers, communications with the manufacturer, and any corrective actions taken.
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Product Details
Model No. BF-1T150; UDI 4953170308185; All Serial No.; Sold to healthcare providers nationwide in the United States; Quantity recalled: 3 US units; 1,987 units outside the United States (OUS); Distribution: US nationwide.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Total quantity recalled: 1,990 units (US 3; OUS 1,987).
- Model No. BF-1T150; UDI 4953170308185.
- Distribution: US nationwide; All serial numbers affected.
- Hazard level: HIGH; Remedy: stop using and follow manufacturer instructions.
- FDA recall reference: Z-0045-2026.
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Safety Guide
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