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, Unknown
- 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
- Bronchovideoscope
- Model numbers
- BF-XT190
- Sold at
- Multiple Retailers, Unknown
- 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-XT190 bronchovideoscope is used in bronchoscopy procedures to visualize airways. It is involved in procedures using adjunctive laser, APC, or high-frequency therapy equipment.
Why This Is Dangerous
IFU updates clarify safe and effective use when combined with certain energy devices. Misuse could lead to procedural complications.
Industry Context
This recall is not part of a broader industry pattern at this time.
Real-World Impact
Clinicians may need to pause procedures involving the BF-XT190 while awaiting updated instructions.
Practical Guidance
How to identify if yours is affected
- Check model BF-XT190
- Confirm serial numbers are all affected
- Review latest Olympus recall communications
Where to find product info
Official recall notices and FDA enforcement page Z-0066-2026
What timeline to expect
Remedies and guidance will be communicated by Olympus; timeline will vary by facility.
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Contact Olympus customer support directly
- File a consumer safety complaint if needed
How to prevent similar issues
- Verify device compatibility with laser, APC, and HF therapy equipment before procedures
- Monitor for updated IFU documentation
- Maintain a clear log of all recall communications
Documentation advice
Keep recall notices, purchase records, serial numbers, and all correspondence with Olympus.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Brand: Olympus Corporation of the Americas. Product: EVIS EXERA b Bronchovideoscope BF-XT190. Model No.: BF-XT190. UDI: 4953170402470. Serial numbers: All serial numbers affected. Units recalled: 361 in the US; 258 overseas. Distribution: US nationwide.
Reported Incidents
No injuries or incidents have been reported in the recall notice. The hazard level is classified as HIGH due to potential misapplication risks.
Key Facts
- BF-XT190 model with UDI 4953170402470 affected
- Total units recalled: 619 (US 361, OUS 258)
- Active recall status as of 2025-10-22
- Classification: Class I recall
- Reason: Additional IFU updates for safer use with laser, APC, and HF therapy equipment
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.