HIGH

OLYMPUS BF-1T150 Bronchoscope Recall in 2025 for Updated IFU on Safe Use

Olympus Corporation of the Americas recalled 1,990 BF-1T150 bronchoscopes distributed nationwide to healthcare providers. The recall updates the IFU to clarify safe use with laser, argon plasma coagulation and high-frequency therapy equipment. Healthcare facilities should stop using the devices immediately and follow the manufacturer’s recall instructions.

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

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 medical devices used to inspect airways and perform procedures. The BF-1T150 is a model in Olympus’ bronchoscope lineup intended for diagnostic and therapeutic use by trained clinicians.

Why This Is Dangerous

The recall updates the IFU to clarify safe and effective use when the bronchoscope is used with laser, APC and high-frequency therapy equipment, reducing the potential for misuse during procedures.

Industry Context

This recall is not described as part of a broader industry pattern.

Real-World Impact

Hospitals and clinics using these devices with adjunctive therapy equipment should review and implement updated instructions. No injuries were reported in the recall data available.

Practical Guidance

How to identify if yours is affected

  1. Verify model number BF-1T150 on the device label.
  2. Check UDI 4953170308185 on the device packaging or label.
  3. Note that all serial numbers are affected.
  4. Cross-check the FDA recall reference Z-0045-2026.

Where to find product info

Identifiers appear on the bronchoscope label and packaging. The FDA recall page provides official guidance.

What timeline to expect

Recall actions involve updating IFU and provider communications. No refunds are noted; follow manufacturer instructions. Timelines will be issued by,,

If the manufacturer is unresponsive

  • Escalate to FDA/Regulatory authorities if the manufacturer is unresponsive.
  • Document all communications and actions taken.

How to prevent similar issues

  • Ensure you are using the updated IFU with all applicable equipment.
  • Provide staff training on safe use with laser, APC and HF devices.
  • Establish a procedure to verify device documentation at point of care.

Documentation advice

Keep a copy of the recall notice, model number, UDI, serial numbers, communications with the manufacturer, and any corrective actions taken.

Product Details

Model No. BF-1T150; UDI 4953170308185; All Serial No.; Sold to healthcare providers nationwide in the United States; Quantity recalled: 3 US units; 1,987 units outside the United States (OUS); Distribution: US nationwide.

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Total quantity recalled: 1,990 units (US 3; OUS 1,987).
  • Model No. BF-1T150; UDI 4953170308185.
  • Distribution: US nationwide; All serial numbers affected.
  • Hazard level: HIGH; Remedy: stop using and follow manufacturer instructions.
  • FDA recall reference: Z-0045-2026.

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
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
BF-1T150
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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