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, 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-XT40
- 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 flexible endoscopes used to visualize the airways. The BF-XT40 is an Olympus model used in diagnostic and therapeutic procedures.
Why This Is Dangerous
The recall updates IFU to clarify safe use when combined with laser, APC and high-frequency therapy equipment, aiming to prevent procedural misuse.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Hospitals and clinics should review updated IFU and training materials. Immediate action is required to stop use until guidance is applied.
Practical Guidance
How to identify if yours is affected
- Confirm model BF-XT40 in use
- Verify the device has updated IFU as described in Olympus communications
- Cross-check serial numbers: all serial numbers affected
Where to find product info
IFU updates and recall notices available from Olympus and FDA enforcement pages
What timeline to expect
Not specified in the recall. Follow Olympus instructions and FDA updates for remediation timelines
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a consumer complaint with the FDA if applicable
- Consult legal counsel if patient safety is at risk
How to prevent similar issues
- Ensure IFU is current for all bronchoscopic devices
- Require training on device-associated equipment before procedures
- Monitor manufacturer updates for IFU changes related to equipment compatibility
Documentation advice
Keep recall notice, update IFU documents, training records, and incident reports for compliance and audits
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Product Details
Model No.: BF-XT40. Distribution: US nationwide distribution; 705 units outside the US. When sold and price not provided. Serial numbers: All serial numbers affected.
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 821 total units recalled (US 116; OUS 705)
- Recall date 2025-09-11; status ACTIVE
- Hazard: updated IFU for use with laser, APC, and HF equipment
- Remedy: stop use and follow manufacturer instructions
- Replacement guidance: consult Olympus for next steps (IFU updates)
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Safety Guide
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