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
- Bronchovideoscope
- Model numbers
- BF-P180, BF-P180 UDI 4953170339288, All Serial No.
- 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
The EVIS EXERA II BF-P180 bronchovideoscope is a flexible instrument used in bronchoscopy to visualize airways. It is typically employed by trained clinicians during diagnostic and interventional procedures.
Why This Is Dangerous
The recall targets updated Instructions for Use to ensure safe and effective operation when the bronchoscope is used with laser, argon plasma coagulation and high-frequency therapy devices. Misuse or deviation from the updated guidelines could pose risks to patients.
Industry Context
This recall is not stated as part of a broader industry pattern.
Real-World Impact
Clinicians must review updated guidance and pause use of affected devices until instructions are followed. The recall emphasizes preventing misuse in conjunction with adjunct equipment.
Practical Guidance
How to identify if yours is affected
- Verify model BF-P180 and UDI 4953170339288
- Check that the device serial number matches All Serial No.
- Confirm the device is part of the recall by reviewing the latest Olympus guidance
- Review the updated IFU for safe use with laser, APC and HF therapy equipment
Where to find product info
UDI 4953170339288 and model BF-P180 are on the device label; official recall notices are available through the FDA recall page linked in the article.
What timeline to expect
Not specified by the recall; healthcare providers should follow Olympus guidance and monitor updates.
If the manufacturer is unresponsive
- Escalate with hospital risk management and the medical device manufacturer
- File a complaint with the FDA if appropriate
- Consult legal counsel if patient harm arises and manufacturer is unresponsive
How to prevent similar issues
- Always verify device compatibility with adjunct equipment before procedures
- Ensure updated IFU is in use historically; keep current recall notices accessible
- Establish clear internal SOPs for recalling or replacing devices
- Prefer devices with clearly documented safety updates and post-market surveillance
Documentation advice
Keep copies of recall notices, model UDIs, serial numbers and correspondence with Olympus; document any device usage with adjunct equipment during procedures
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Product Details
Model No.: BF-P180 UDI: 4953170339288 Serial numbers: All Serial No. Sold at: US nationwide distribution to hospitals and clinics; international distribution to healthcare facilities Quantity: US 1,070 units; OUS 2,180 units Price: Unknown Sold since: Unknown
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Total units recalled worldwide: 3,250 (US 1,070; OUS 2,180)
- Model BF-P180; UDI 4953170339288; All Serial No.
- Recall status: ACTIVE; Recall date 2025-09-11; Report date 2025-10-22
- Hazard: Updated IFU to clarify safe use with laser, APC, and HF therapy equipment
- Remedy: Stop using the device immediately; contact Olympus for instructions
- No injuries reported; No confirmed patient harm at this time; Follow-up guidance pending
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