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
- 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
- Bronchoscope
- Model numbers
- BF-P150, BF-P150 (BF TYPE P150)
- Sold at
- 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
Bronchoscopes are flexible tubes used for airway examination and intervention. The BF-P150 is used in various procedural settings.
Why This Is Dangerous
IFU updates affect how the device is used with laser, APC, and HF therapy equipment, which could lead to unsafe operation if not followed.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
High hazard requires immediate attention by healthcare providers to ensure safe device use and proper recall adherence.
Practical Guidance
How to identify if yours is affected
- Verify model BF-P150 and UDI 4953170308178
- Check serial numbers for All Serial No.
- Confirm distribution outside the U.S. and 0 in U.S.
Where to find product info
FDA recall page Z-0055-2026; manufacturer instructions
What timeline to expect
Refunds or replacements coordinated through Olympus and distributors; timelines vary
If the manufacturer is unresponsive
- Escalate to hospital regulatory affairs
- File a complaint with the FDA if necessary
- Consult your institution's risk management
How to prevent similar issues
- Verify IFU is the latest version before procedures
- Ensure compatibility with laser, APC, and HF therapy equipment
- Regular training on device use and updated guidelines
Documentation advice
Keep recall notice, update communications, and any correspondence with Olympus or distributors
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Product Details
Brand: Olympus Corporation of the Americas. Product: BRONCHOVIDEOSCOPE BF TYPE P150. Model No.: BF-P150. UDI: 4953170308178. Serial numbers: All Serial No. Units: 1,019 outside the U.S.; 0 in U.S.
Reported Incidents
No injuries or incidents are mentioned in the provided data. The recall status is ACTIVE and classified HIGH risk.
Key Facts
- BF-P150 model with UDI 4953170308178
- All serial numbers affected
- US distribution nationwide; 1,019 units outside US
- Recall status: ACTIVE; Hazard level HIGH
- IFU updates for safe use with laser, APC, and HF therapy equipment
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Safety Guide
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