FDA Recall: Olympus
Source: FDA
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FDA Recall: Olympus

Olympus • November 03, 2025

FDA Recall Alert: Olympus Bronchoscope Labeling Updated to Mitigate Endobronchial Combustion Risk

URGENT: Olympus bronchoscopes used with laser, APC, or high-frequency cautery can ignite endobronchial combustion. Review and follow the new Instructions for Use immediately.

Olympus Corporation has released a voluntary, worldwide labeling correction for multiple Olympus bronchofiberscope and bronchovideoscope models. The action follows new reports of severe airway burns—including one fatality—linked to laser or energy–based procedures inside the lungs. Healthcare teams must adopt the revised Instructions for Use (IFU) to reduce patient harm and comply with the FDA recall notice.

Olympus Bronchoscope Recall Details (At-a-Glance)

  • Announcement date: October 31, 2025
  • FDA post date: November 3, 2025
  • Product category: Medical devices – bronchoscopes
  • Affected brand: Olympus
  • Hazard: Endobronchial combustion when used with laser, argon plasma coagulation (APC), or high-frequency cautery
  • Reported outcomes: 4 serious injuries and 1 prior death (since 2023)

Sources

Patient Safety Risks Associated with Olympus Bronchoscopes

If combustion ignites inside the airway, patients may suffer:

  • Severe internal burns and airway edema
  • Procedure interruption or abandonment
  • Extended intensive-care unit (ICU) stays
  • Fragments of damaged bronchoscope components left in the airway
  • Death in extreme cases

Required Olympus Bronchoscope Safety Actions for Healthcare Providers

  • Maintain a minimum 4 cm gap between the bronchoscope tip and the endotracheal tube.
  • Keep delivered oxygen concentration (FiO2) below 40% throughout energy delivery.
  • Limit laser/APC/cautery power settings to under 40 W.
  • Avoid continuous energy application on one spot; use intermittent bursts.
  • Suction smoke promptly to reduce residual oxygen and heat.
  • Ensure all staff have received and signed off on the September 2025 updated IFU.

Olympus Recall Compliance Steps for Facilities

Product returns are not requested. Instead, facilities should:

  1. Identify every Olympus bronchofiberscope and bronchovideoscope used with energy devices.
  2. Distribute the revised labeling to all clinicians and reprocessing personnel.
  3. Document competency training and adherence to the new energy-use limitations.
  4. Report any suspected adverse events to FDA MedWatch and to Olympus.

Olympus Recall Contact Information

Frequently Asked Questions

1. Which Olympus bronchoscopes are included in the 2025 FDA recall?

The correction covers all Olympus bronchofiberscopes and bronchovideoscopes that may be paired with laser therapy, argon plasma coagulation, or high-frequency cautery equipment. Refer to the model list provided in the September 2025 customer letter.

2. Why did the FDA recall Olympus bronchoscopes used for laser procedures?

The updated labeling addresses the risk of endobronchial combustion—a fire inside the airway—when high oxygen levels and energy settings are applied too close to the bronchoscope tip.

3. How can I confirm if my Olympus scope is affected?

Match each scope’s model number and serial number to those listed in Olympus’s customer notification. If the scope is used with any laser, APC, or cautery device, treat it as impacted.

4. Should my facility stop using Olympus bronchoscopes altogether?

No. The devices can remain in service if all users follow the revised IFU guidance on oxygen concentration, distance, and power settings.

5. What injuries have been linked to the Olympus bronchoscope recall?

Since 2023, Olympus has reported four serious burn injuries and one death due to airway combustion during energy-based procedures.

6. How do I document staff training on the updated Olympus IFU?

Create a competency checklist, record completion dates, and file signed acknowledgements in accordance with your facility’s quality-management system and regulatory requirements.

7. Where can I get technical support for Olympus bronchoscope settings?

Call the Olympus Technical Assistance Center at 1-800-848-9024 (Option 1) or email complaints@olympus.com for configuration guidance.

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