HIGH

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

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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

  1. Confirm model BF-P190 and UDI 4953170342110.
  2. Verify all serial numbers are affected per the recall notice.
  3. 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

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
5/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Brand
Model Numbers
BF-P190
UDI: 4953170342110
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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