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-PE2, BF-PE2
- 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 visualize and sample airways. They may be used in procedures that involve laser or energy-based devices.
Why This Is Dangerous
The updated IFU aims to prevent misuse during procedures that involve laser, argon plasma coagulation, and high-frequency devices by clarifying safe and effective use.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
The recall could delay procedures unless mitigated by updated instructions and clear usage guidance.
Practical Guidance
How to identify if yours is affected
- Check model BF-PE2
- Confirm UDI 4953170339974 on device label
- Verify serial numbers included in recall scope
- Review updated IFU provided by Olympus
Where to find product info
FDA recall page linked in notice; Olympus customer support
What timeline to expect
Remedies and replacement instructions will be issued by Olympus; expect communication within weeks
If the manufacturer is unresponsive
- Document all contact attempts
- Escalate to FDA recall press contacts if manufacturer is unresponsive
- Seek alternate suppliers for essential procedures
How to prevent similar issues
- Always verify compatibility with laser and energy devices before procedure
- Ensure updated IFU is accessible in clinical settings
- Maintain inventory of recalled devices separately
- Train staff on updated safety guidance
Documentation advice
Keep the recall notice, purchase records, serial numbers, and all correspondence with Olympus
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Product Details
Brand: Olympus Corporation of the Americas. Product: BRONCHOFIBERSCOPE BF TYPE PE2. Model No.: BF-PE2. UDI: 4953170339974. Serial numbers: All serial numbers. Sold/distributed: US nationwide and international distribution. Recall date: 2025-09-11. Status: ACTIVE.
Reported Incidents
No specific incidents or injuries are cited in the recall notice. The hazard level is listed as HIGH due to potential misuse if IFU are not followed.
Key Facts
- 2 units US recalled
- 4,289 units OUS recalled
- Class I recall
- All serial numbers affected
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Safety Guide
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