HIGH

Olympus BF-P150 Bronchoscope Recall Expanded Over IFU Clarifications (2025)

Olympus Corporation of the Americas recalls its BF-P150 bronchoscope after updates to the instruction for use. The recall covers 1,019 units outside the U.S. Distribution was nationwide in the U.S. The agency classifies this as a high-hazard issue.

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
Unknown
Geographic Scope
1 states
At-Risk Groups
GENERAL, PREGNANT, PREGNANT

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

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About This Product

Bronchoscopes are flexible tubes used for airway examination and intervention. The BF-P150 is used in various procedural settings.

Why This Is Dangerous

IFU updates affect how the device is used with laser, APC, and HF therapy equipment, which could lead to unsafe operation if not followed.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

High hazard requires immediate attention by healthcare providers to ensure safe device use and proper recall adherence.

Practical Guidance

How to identify if yours is affected

  1. Verify model BF-P150 and UDI 4953170308178
  2. Check serial numbers for All Serial No.
  3. Confirm distribution outside the U.S. and 0 in U.S.

Where to find product info

FDA recall page Z-0055-2026; manufacturer instructions

What timeline to expect

Refunds or replacements coordinated through Olympus and distributors; timelines vary

If the manufacturer is unresponsive

  • Escalate to hospital regulatory affairs
  • File a complaint with the FDA if necessary
  • Consult your institution's risk management

How to prevent similar issues

  • Verify IFU is the latest version before procedures
  • Ensure compatibility with laser, APC, and HF therapy equipment
  • Regular training on device use and updated guidelines

Documentation advice

Keep recall notice, update communications, and any correspondence with Olympus or distributors

Product Details

Brand: Olympus Corporation of the Americas. Product: BRONCHOVIDEOSCOPE BF TYPE P150. Model No.: BF-P150. UDI: 4953170308178. Serial numbers: All Serial No. Units: 1,019 outside the U.S.; 0 in U.S.

Reported Incidents

No injuries or incidents are mentioned in the provided data. The recall status is ACTIVE and classified HIGH risk.

Key Facts

  • BF-P150 model with UDI 4953170308178
  • All serial numbers affected
  • US distribution nationwide; 1,019 units outside US
  • Recall status: ACTIVE; Hazard level HIGH
  • IFU updates for safe use with laser, APC, and HF therapy equipment

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERALPREGNANTPREGNANT
Injury Types
OTHER

Product Details

Model Numbers
BF-P150
BF-P150 (BF TYPE P150)
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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