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, PETS
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-H190
- 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 BF-H190 is a bronchoscope used in diagnostic and therapeutic airway procedures. It may be used with laser, argon plasma coagulation and high-frequency therapy equipment during complex interventions.
Why This Is Dangerous
The recall addresses updated IFU guidance. The risk relates to safe and effective use during procedures that involve energy-based devices.
Industry Context
This recall is not part of a broader industry pattern identified in the provided data.
Real-World Impact
Medical professionals must verify guidance before procedures. The recall may affect scheduling of procedures and replacement parts. There is potential for delays in care if guidance is not followed.
Practical Guidance
How to identify if yours is affected
- Verify device model BF-H190
- Confirm all serial numbers are included
Where to find product info
UDI plate and device labeling contain the UDI; manufacturer guidance documents contain the IFU update details
What timeline to expect
Refunds or replacements are handled per Olympus guidance; exact timeline not provided
If the manufacturer is unresponsive
- Escalate to hospital risk management
- File a complaint with the FDA if needed
- Consult legal counsel if care delays occur
How to prevent similar issues
- Always use the latest IFU during procedures
- Verify compatibility with equipment before procedure
- Document procedure deviations and updated instructions
Documentation advice
Keep recall notice, communication with Olympus, and any replacement IFU materials
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Product Details
Product: EVIS EXERA III BRONCHOVIDEOSCOPE BF-H190. Brand: Olympus Corporation of the Americas. Model: BF-H190. UDI: 4953170335174. Serial numbers: All serial numbers affected. Units recalled: 5,221 in the United States; 4,321 outside the United States. Distribution: US nationwide.
Reported Incidents
No specific injuries or incidents are reported in the provided data.
Key Facts
- 5,221 units recalled in the U.S.; 4,321 units outside the U.S.
- Model BF-H190; UDI 4953170335174; all serial numbers affected
- Recall date 2025-09-11; report date 2025-10-22; status ACTIVE
- High hazard level; Class I recall
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Safety Guide
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