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Bronchofiberscopes and bronchovideoscopes Recall Due to Potential for endobro...

# Major Recall Alert: Bronchofiberscopes and Bronchovideoscopes Recalled Due to Potential for Endobronchial Combustion

Olympus, a leading medical device manufacturer, has issued an urgent recall concerning their bronchofiberscopes and bronchovideoscopes. The recall, announced on **October 31, 2025**, highlights the potential for **endobronchial combustion** when these devices are used in conjunction with certain therapeutic instruments such as laser therapy, argon plasma coagulation, or high-frequency cauterization equipment. Here's everything you need to know about this critical recall that could directly impact patient safety.

## Why This Recall is Important

The risk of **endobronchial combustion** presents a serious danger to patients undergoing tracheobronchial procedures. This phenomenon occurs when high-energy instruments, combined with excessive oxygen levels, interact with the device's distal end inside the body's airway. Such incidents can lead to:
- **Life-threatening internal burns** to the airway or lungs.
- **Extended immobilization** and hospitalization, including ICU admission.
- **Potential fatalities**—with one death already linked to this issue.
- **Device breakage risks**, requiring possible retrieval or surgical removal of components.

In light of this, Olympus reevaluated their devices’ instructions for use (IFUs) after receiving **four additional reports of serious injury, including one in the U.S., since their prior advisory in 2023.** This voluntary recall ensures healthcare professionals are better equipped with updated guidelines for safe device usage during certain high-risk procedures.

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## Details of the Recall

**Products Impacted:**
- Bronchofiberscopes
- Bronchovideoscopes

**Manufacturer:** Olympus Corporation

### Recall Reasons:
- Risk of **endobronchial combustion** stemming from combined use with therapeutic instruments like laser therapy, argon plasma coagulation, or high-frequency cauterization equipment.
- Insufficient oxygen management or improper device placement during procedures may elevate this risk.

### Updated Safety Measures Include:
To mitigate risks, Olympus has revised its user instructions, requiring:
- Maintaining at least **4cm separation** between the device and the endotracheal tube.
- Using oxygen levels **below 40%** during procedures.
- Limiting energy output to **less than 40 watts.**
- Avoiding prolonged energy application to a single spot.
- Employing **suction** to efficiently evacuate smoke during procedures.

Failing to adhere to these guidelines could lead to catastrophic events or severe patient injury. Healthcare providers have received a letter (as of September 2025) with detailed guidance on these updates. Olympus urges all medical personnel using their devices to thoroughly familiarize themselves with the revised instructions.

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## What You Should Do

If you are a clinician, healthcare provider, or institution currently using Olympus bronchofiberscopes or bronchovideoscopes, follow these steps:
1. **Review the September 2025 customer letter** detailing the updated instructions for safe use.
2. Ensure all medical and technical staff are thoroughly trained on the revisions.
3. Use the devices strictly according to updated safety guidelines to avoid potential combustion risks.
4. Report any adverse effects or device quality concerns to the FDA’s MedWatch online system at [FDA MedWatch](https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda).

For immediate assistance or additional queries about the recall, contact the Olympus Technical Assistance Center at **1-800-848-9024 (Option 1)** or email **complaints@olympus.com**.

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## Stay Safe – Get Instant Recall Alerts

Medical recalls like these emphasize the importance of staying informed about the products impacting patient care. With life-threatening risks such as **endobronchial combustion**, keeping up-to-date with product guidelines and recalls is essential for your safety and the safety of your patients.

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**Source:** For further details on this recall, visit the official FDA notice [here](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/olympus-issues-voluntary-labeling-update-bronchoscopes-used-laser-therapy-equipment).

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