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Olympus EVIS EXERA II BF-1T180 Bronchovideoscope Recall for IFU Update — 5,247 Units (2025)

Olympus Corporation of the Americas recalled 1,473 US units and 3,774 non-US units of the EVIS EXERA II bronchovideoscope BF-1T180. The recall concerns updated instructions for safe use with laser, argon plasma coagulation, and high-frequency therapy equipment. Stop using the device immediately and follow manufacturer instructions.

Official notice

Source-backed recall notice

No product image was available from the source feed.

Official source
FDA DEVICE
Recall date
September 11, 2025
Status
ACTIVE
Severity
7/10

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

What to Do Now

Use this page like a recall checklist: verify the product first, then act on the official remedy.

Immediate steps

  1. 1Stop using the product until you confirm whether it is included in the recall.
  2. 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
  3. 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
  4. 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.

Check these identifiers

Brand
Olympus
Product type
Bronchovideoscope
Model numbers
BF-1T180
Sold at
Multiple Retailers
Where affected
ALL

Recall Timeline

Key dates and source checks for this recall record.

  1. Recall announced

    September 11, 2025

  2. Reported by FDA DEVICE

    October 22, 2025

  3. RecallRadar source check

    April 18, 2026

  4. Consumer action

    Use the official remedy and keep documentation.

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

About This Product

The bronchovideoscope is a flexible endoscope used to visualize the airways during bronchoscopy. It aids diagnosis and treatment planning in respiratory conditions.

Why This Is Dangerous

The recall cites updates to the instruction for use to clarify safe use when the device is used with laser, APC, and high-frequency therapy equipment. Misinterpretation or improper use could endanger patients during procedures.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Hospitals and clinics must review updated IFU guidance and retrain staff on safe integration with adjunct devices. No injuries have been reported in the notice, but the risk is elevated if instructions are not followed.

Practical Guidance

How to identify if yours is affected

  1. Confirm model BF-1T180 on the device label
  2. Check UDI 4953170339325 on packaging or documentation
  3. Verify that the serial number is included (All Serial Nos)

Where to find product info

IFU update notices and device labeling; manufacturer website and recall notices

What timeline to expect

Timeline for remediation not specified in the recall

If the manufacturer is unresponsive

  • Document all attempts to contact Olympus
  • Escalate to hospital risk management or purchasing department
  • File a consumer safety report with appropriate authorities if needed

How to prevent similar issues

  • Ensure updated IFUs are available and accessible in clinical settings
  • Train staff on safe use with laser, APC, and HF equipment
  • Verify device compatibility before procedures
  • Keep records of recall communications and action taken

Documentation advice

Retain recall notice, model and UDI information, serial numbers, dates of recall-related actions, and correspondence with Olympus.

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Product Details

Model No.: BF-1T180 UDI: 4953170339325 Serial numbers: All serial numbers Quantity: 1,473 US units; 3,774 units outside the US Sold in: US nationwide distribution Sold From: Unknown Price: Unknown

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • Total units recalled: 5,247 (1,473 US, 3,774 outside US)
  • Model No. BF-1T180; UDI 4953170339325; All serial numbers affected
  • Recall status: ACTIVE; Hazard Level HIGH; Classification Class I
  • Remedy: Stop using immediately; contact Olympus or healthcare provider for instructions
  • Distribution: US nationwide distribution; additional units outside the US
  • Recall date: 2025-09-11; Report date: 2025-10-22

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

Brand
Model Numbers
BF-1T180
Affected States
ALL
Report Date
October 22, 2025
Recall Status
ACTIVE

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