Olympus BF-P190 Bronchoscope Recall Updated for 2025 IFU Guidance
Olympus recalls 3,046 BF-P190 bronchovideoscopes sold nationwide in the US and 2,414 overseas. The recall centers on updated IFU guidance to clarify safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Clinicians and facilities should stop using the device immediately and follow Olympus recall instructions.
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
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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
No spamUnsubscribe anytime
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
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
Mazda North American Operations is recalling 2024 CX-90 and 2025 CX-70 SUVs sold through Mazda dealers. The PCM and ECM software can illuminate malfunction indicator lights and cause a loss of drive power, increasing crash risk. Owner notification letters were mailed December 19, 2024, and Mazda will reprogram the PCM and ECM at no charge.
Mazda North American Operations recalls 2025 Mazda CX-70 plug-in hybrids as software issues in the inverter may cause the malfunction indicator lights to illuminate and a loss of drive power in EV mode. Dealers will update inverter software at no cost. Letters were mailed December 19, 2024.
Mazda North American Operations recalls certain 2024-2025 CX-90 and 2025 CX-70 vehicles with a Dash ESU due to startup function failures. Software reprogramming will remedy the issue at no charge. Owner notices were mailed December 18, 2024. Contact Mazda at 1-800-222-5500 Option 6. NHTSA ID 24V814000.
Subaru recalls 2025 Forester vehicles due to potentially loose child seat anchor bolts. Dealers will inspect and tighten bolts at no charge. Owner letters are expected August 15, 2025. Contact Subaru at 1-844-373-6614. Recall number WRC-25.
Nissan recalls 2025 Pathfinder, Murano and INFINITI QX60 for front brake caliper weakness that could fail. Dealers will inspect and replace calipers as needed, free of charge. Letters sent May 9, 2025. Contact Nissan or INFINITI for remedies.
Mazda North American Operations is recalling 2025 CX-50 Hybrid and CX-50 SUVs sold through Mazda dealers. Incorrectly configured restraint-control software may cause the air bag to deploy improperly. Owner notification letters are expected to be mailed August 17, 2025.
Nissan North America is recalling certain 2025 Nissan Kicks vehicles sold through Nissan dealers nationwide. The certification label may print incorrect GVWR and GAWR values, risking overload. Some SR trims with a 19-inch wheel package may display an incorrect wheel size on the label, and owners should contact their Nissan dealer to arrange replacement labels.
Chrysler is recalling 2024-2025 Pacifica minivans after a radio installed during production could fail to display the rearview camera image. Dealers will replace the radio at no cost. Owner letters were mailed August 7, 2025. Contact Chrysler customer service at 800-853-1403 for details.