Quick Facts at a Glance
- Recall Date
- September 11, 2025
- Hazard Level
- HIGH
- Brand
- Olympus
- 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
- Product type
- Bronchoscope
- Model numbers
- BF-P190, UDI: 4953170342110
- 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
Bronchovideoscopes are used by respiratory specialists to visualize airways during bronchoscopy. They are part of diagnostic and therapeutic procedures.
Why This Is Dangerous
The issue relates to updated IFU clarity for safe and effective use with laser, APC, and high-frequency therapy equipment, which could affect procedural safety if misapplied.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Clinicians must verify guidance before use. Delay in proper instruction could impact patient safety during complex endoscopic therapies.
Practical Guidance
How to identify if yours is affected
- Confirm model BF-P190 and UDI 4953170342110.
- Verify all serial numbers are affected per the recall notice.
- Check the hospital inventory against the recall list.
Where to find product info
FDA recall page for Z-0057-2026 and Olympus recall communications
What timeline to expect
Remedies and instructions will be issued by Olympus through the recall process; no specific timeline provided
If the manufacturer is unresponsive
- Escalate to hospital risk management or compliance
- Contact FDA recall enforcement for guidance
- Consult legal counsel if needed for patient safety concerns
How to prevent similar issues
- Verify IFU compatibility for devices used with laser, APC, HF therapy equipment before procedures
- Keep device documentation updated with manufacturer recalls
- Establish a standard risk-management review for endoscopy equipment
Documentation advice
Retain recall notices, model/UDI, serial numbers, correspondence with Olympus, and any replacement or refund documents
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Model BF-P190 UDI 4953170342110 All Serial Numbers affected Quantity recalled: 3,046 US units; 2,414 outside US Sold/distributed: US nationwide; worldwide distribution Recall date: 2025-09-11 Status: ACTIVE Brand: Olympus Corporation of the Americas Category: Health & Personal Care, Medical Devices
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- 3,046 US units recalled; 2,414 units overseas
- Model BF-P190; UDI 4953170342110; All Serial Numbers affected
- Recall date 2025-09-11; Status ACTIVE
- Distribution: US nationwide; overseas distribution
- Hazard: Updated IFU for 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.