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
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
- Bronchofiberscope
- Model numbers
- BF-P60
- 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
Bronchofiberscopes are flexible endoscopes used to examine the airways and assist in airway-related procedures.
Why This Is Dangerous
The recall updates safety guidance to ensure proper use with laser, APC and high-frequency therapy equipment to prevent misuse and potential patient harm.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Hospitals and clinicians should implement updated IFU guidance. Workflow changes may be needed, and there could be delays in device availability during transition.
Practical Guidance
How to identify if yours is affected
- Verify model BF-P60 is in use
- Check UDI 4953170339196 on the device packaging or documentation
- Review the manufacturer’s recall instructions and FDA posting
- Stop using the device until guidance is received
- Contact Olympus for remediation options (refund/replacement)
Where to find product info
FDA enforcement page for Z-0058-2026 and the manufacturer’s recall notices
What timeline to expect
Remediation timelines vary by institution; anticipate several weeks for approvals and implementation
If the manufacturer is unresponsive
- Document all recall communications
- Escalate to the hospital’s supply chain leadership
- File a complaint with the FDA if the issue remains unresolved
How to prevent similar issues
- Request updated IFU documentation when purchasing bronchoscopes
- Verify devices include the latest safety guidelines from the manufacturer
- Provide staff training on new usage protocols for laser, APC and HF therapy equipment
- Maintain a recall tracking system for all medical devices
Documentation advice
Keep the recall notice, UDI, model BF-P60 documentation, and all correspondence with the manufacturer. Document staff training and protocol updates.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model No.: BF-P60 UDI: 4953170339196 Sold in: US nationwide; international (OUS) Quantity recalled: 1,007 US units; 5,443 OUS units; total 6,450 Price: Unknown Recall date: 2025-09-11 Status: ACTIVE Manufacturer: Olympus Corporation of the Americas Additional notes: All serial numbers affected
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 6,450 total units recalled (1,007 US; 5,443 outside US)
- Model BF-P60; UDI 4953170339196
- Recall status ACTIVE as of 2025-10-22
- IFU updates address safe 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.