HIGH

Olympus BF-1TH1100 Bronchoscope Recall Expanded for IFU Clarifications (2025)—High Risk

Olympus Corporation of the Americas reports an active recall for the BRONCHOVIDEOSCOPE BF-1TH1100. The recall concerns additional IFU updates for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. The company urges stopping use and following 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
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

Bronchovideoscopes are used by healthcare professionals to view airways during bronchoscopy. They enable diagnosis and treatment of lung conditions.

Why This Is Dangerous

IFU updates are to clarify safe use when paired with energy devices like lasers and argon plasma coagulation. Misuse could lead to improper operation or patient risk.

Industry Context

This recall is not described as part of a broader industry pattern in the provided data.

Real-World Impact

Immediate halt in use; reliance on updated IFU to ensure safe operation in complex procedures.

Practical Guidance

How to identify if yours is affected

  1. Verify model BF-1TH1100 and UDI 4953170424199
  2. Confirm serial numbers against manufacturer records
  3. Review latest FDA recall page for updated IFU

Where to find product info

FDA recall page and Olympus customer support for product identifiers and instructions

What timeline to expect

Remedy processing times vary; follow official instructions for timelines

If the manufacturer is unresponsive

  • Document all communications
  • Escalate to hospital risk management or regulatory bodies if needed
  • Consider contacting consumer protection agencies if manufacturer is nonresponsive

How to prevent similar issues

  • Ensure bronchoscopy equipment is always used with the latest updated IFU
  • Verify compatibility with laser and coagulation devices before use
  • Attend required training on energy-device assisted bronchoscopy
  • Keep updated recall communications from the manufacturer
  • Document all device checks and procedure notes

Documentation advice

Keep recall notice, model and UDI details, communications with manufacturer, and any updated IFU for records

Product Details

Model No. BF-1TH1100. UDI: 4953170424199. All Serial No. US distribution not specified; 1,913 units in outside U.S. distribution. Sold nationwide in the U.S.; 0 units in the U.S. currently recalled.

Reported Incidents

No specific injuries or incidents are reported in the provided data.

Key Facts

  • BF-1TH1100
  • UDI 4953170424199
  • 1,913 units outside the U.S.
  • 0 units in U.S. currently recalled
  • Active recall as of 2025-09-11
  • Hazard level: HIGH

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
GENERALPREGNANTPREGNANTPETS
Injury Types
ELECTRICALLACERATIONBURNSUFFOCATIONOTHER

Product Details

Model Numbers
BF-1TH1100
BF-1TH1100
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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