Olympus Bronchoscopes Recalled for Thermal Therapy Safety Updates

Agency Publication Date: October 16, 2025

Summary

Olympus Corporation of the Americas is recalling 19,457 units of various bronchoscope models to update their Instructions for Use. The updates provide essential safety clarifications for using these devices alongside thermal therapy equipment, such as lasers, argon plasma coagulation, and high-frequency therapy devices. This recall affects a wide range of models, including the BF-1T150, BF-1T180, and EVIS EXERA III series.

Risk

Using these bronchoscopes with thermal therapy equipment without the clarified instructions could lead to device damage or patient injury, including internal thermal burns. No specific injuries have been reported in the provided data, but the recall is classified as critical due to the potential for severe harm.

What You Should Do

This recall affects various Olympus Bronchoscopes, including the BF-1T150, BF-1T180, BF-1T60, BF-1TH1100, BF-1TH190, BF-1TQ170, BF-1TQ180, BF-H1100, BF-H190, BF-MP60, BF-P150, BF-P180, BF-P190, BF-P60, BF-PE2, BF-Q170, BF-Q180, BF-Q180-AC, BF-Q190, BF-TE2, BF-XT160, BF-XT190, and BF-XT40.
Identify your device by checking the model number and UDI label on the device or its original packaging. See the Affected Products section below for the full list of affected codes.
Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.
Contact Olympus Corporation of the Americas directly for further instructions and to obtain the updated Instructions for Use (IFU) manuals required for safe operation with thermal therapy equipment.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

Other Action

How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

Model / REF:

BF-1T150

Serial Numbers:

All Serial No.

UDI:

4953170308185

Quantity: 3 units US; 1,987 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

Model / REF:

BF-1T180

Serial Numbers:

All Serial No.

UDI:

4953170339325

Quantity: 1,473 units US; 3,774 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

Model / REF:

BF-1T60

Serial Numbers:

All Serial No.

UDI:

4953170339264

Quantity: 347 units US; 2,869 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Model / REF:

BF-1TH1100

Serial Numbers:

All Serial No.

UDI:

4953170424199

Quantity: 0 units US; 1,913 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Model / REF:

BF-1TH190

Serial Numbers:

All Serial No.

UDI:

4953170434778

Quantity: 4,297 units US; 4,290 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

Model / REF:

BF-1TQ170

Serial Numbers:

All Serial No.

UDI:

4953170342943

Quantity: 0 units US; 2,092 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

Model / REF:

BF-1TQ180

Serial Numbers:

All Serial No.

UDI:

4953170339349

Quantity: 215 units US; 736 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Model / REF:

BF-H1100

Serial Numbers:

All Serial No.

UDI:

4953170424229

Quantity: 0 units US; 1,867 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Model / REF:

BF-H190

Serial Numbers:

All Serial No.

UDI:

4953170335174

Quantity: 5,221 units US; 4,321 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

Model / REF:

BF-MP60

Serial Numbers:

All Serial No.

Quantity: 59 units US; 665 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

Model / REF:

BF-P150

Serial Numbers:

All Serial No.

UDI:

4953170308178

Quantity: 0 units US; 1,019 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

Model / REF:

BF-P180

Serial Numbers:

All Serial No.

UDI:

4953170339288

Quantity: 1,070 units US; 2,180 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Model / REF:

BF-P190

Serial Numbers:

All Serial No.

UDI:

4953170342110

Quantity: 3,046 units US; 2,414 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Model / REF:

BF-P60

Serial Numbers:

All Serial No.

UDI:

4953170339196

Quantity: 1,007 units US; 5,443 units OUS

Product: BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

Model / REF:

BF-PE2

Serial Numbers:

All Serial No.

UDI:

4953170339974

Quantity: 2 units US; 4,289 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Model / REF:

BF-Q170

Serial Numbers:

All Serial No.

UDI:

4953170342912

Quantity: 1 unit US; 2,306 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

Model / REF:

BF-Q180

Serial Numbers:

All Serial No.

UDI:

4953170339301

Quantity: 665 units US; 2,250 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Model / REF:

BF-Q180-AC

Serial Numbers:

All Serial No.

UDI:

4953170340086

Quantity: 395 units US; 165 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

Model / REF:

BF-Q190

Serial Numbers:

All Serial No.

UDI:

4953170434792

4953170335198

Quantity: 916 units US; 1,402 units OUS

Product: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Model / REF:

BF-TE2

Serial Numbers:

All Serial No.

UDI:

4953170339998

Quantity: 1 unit US; 5,286 units OUS

Product: EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Model / REF:

BF-XT160

Serial Numbers:

All Serial No.

UDI:

4953170340147

Quantity: 262 units US; 558 units OUS

Product: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Model / REF:

BF-XT190

Serial Numbers:

All Serial No.

UDI:

4953170402470

Quantity: 361 units US; 258 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Model / REF:

BF-XT40

Serial Numbers:

All Serial No.

Quantity: 116 units US; 705 units OUS

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97441

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Hospital supply distributors; Direct sales to medical facilities

Manufactured In: United States

Units Affected: 23 products (3 units US; 1,987 units OUS; 1,473 units US; 3,774 units OUS; 347 units US; 2,869 units OUS; 0 units US; 1,913 units OUS; 4,297 units US; 4,290 units OUS; 0 units US; 2,092 units OUS; 215 units US; 736 units OUS; 0 units US; 1,867 units OUS; 5,221 units US; 4,321 units OUS; 59 units US; 665 units OUS; 0 units US; 1,019 units OUS; 1,070 units US; 2,180 units OUS; 3,046 units US; 2,414 units OUS; 1,007 units US; 5,443 units OUS; 2 units US; 4,289 units OUS; 1 unit US; 2,306 units OUS; 665 units US; 2,250 units OUS; 395 units US; 165 units OUS; 916 units US; 1,402 units OUS; 1 unit US; 5,286 units OUS; 262 units US; 558 units OUS; 361 units US; 258 units OUS; 116 units US; 705 units OUS)

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects various Olympus Bronchoscopes, including the BF-1T150, BF-1T180, BF-1T60, BF-1TH1100, BF-1TH190, BF-1TQ170, BF-1TQ180, BF-H1100, BF-H190, BF-MP60, BF-P150, BF-P180, BF-P190, BF-P60, BF-PE2, BF-Q170, BF-Q180, BF-Q180-AC, BF-Q190, BF-TE2, BF-XT160, BF-XT190, and BF-XT40.

Identify your device by checking the model number and UDI label on the device or its original packaging. See the Affected Products section below for the full list of affected codes.

Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Contact Olympus Corporation of the Americas directly for further instructions and to obtain the updated Instructions for Use (IFU) manuals required for safe operation with thermal therapy equipment.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Affected Products

Product: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T150

Model / REF:

BF-1T150

Serial Numbers:

All Serial No.

UDI:

4953170308185

Quantity: 3 units US; 1,987 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1T180

Model / REF:

BF-1T180

Serial Numbers:

All Serial No.

UDI:

4953170339325

Quantity: 1,473 units US; 3,774 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE 1T60

Model / REF:

BF-1T60

Serial Numbers:

All Serial No.

UDI:

4953170339264

Quantity: 347 units US; 2,869 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-1TH1100

Model / REF:

BF-1TH1100

Serial Numbers:

All Serial No.

UDI:

4953170424199

Quantity: 0 units US; 1,913 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-1TH190

Model / REF:

BF-1TH190

Serial Numbers:

All Serial No.

UDI:

4953170434778

Quantity: 4,297 units US; 4,290 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ170

Model / REF:

BF-1TQ170

Serial Numbers:

All Serial No.

UDI:

4953170342943

Quantity: 0 units US; 2,092 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE 1TQ180

Model / REF:

BF-1TQ180

Serial Numbers:

All Serial No.

UDI:

4953170339349

Quantity: 215 units US; 736 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-H1100

Model / REF:

BF-H1100

Serial Numbers:

All Serial No.

UDI:

4953170424229

Quantity: 0 units US; 1,867 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-H190

Model / REF:

BF-H190

Serial Numbers:

All Serial No.

UDI:

4953170335174

Quantity: 5,221 units US; 4,321 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE MP60

Model / REF:

BF-MP60

Serial Numbers:

All Serial No.

Quantity: 59 units US; 665 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P150

Model / REF:

BF-P150

Serial Numbers:

All Serial No.

UDI:

4953170308178

Quantity: 0 units US; 1,019 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE P180

Model / REF:

BF-P180

Serial Numbers:

All Serial No.

UDI:

4953170339288

Quantity: 1,070 units US; 2,180 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-P190

Model / REF:

BF-P190

Serial Numbers:

All Serial No.

UDI:

4953170342110

Quantity: 3,046 units US; 2,414 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE P60

Model / REF:

BF-P60

Serial Numbers:

All Serial No.

UDI:

4953170339196

Quantity: 1,007 units US; 5,443 units OUS

Product: BRONCHOFIBERSCOPE OLYMPUS BF TYPE PE2

Model / REF:

BF-PE2

Serial Numbers:

All Serial No.

UDI:

4953170339974

Quantity: 2 units US; 4,289 units OUS

Product: BRONCHOVIDEOSCOPE OLYMPUS BF-Q170

Model / REF:

BF-Q170

Serial Numbers:

All Serial No.

UDI:

4953170342912

Quantity: 1 unit US; 2,306 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180

Model / REF:

BF-Q180

Serial Numbers:

All Serial No.

UDI:

4953170339301

Quantity: 665 units US; 2,250 units OUS

Product: EVIS EXERA II BRONCHOVIDEOSCOPE OLYMPUS BF TYPE Q180-AC

Model / REF:

BF-Q180-AC

Serial Numbers:

All Serial No.

UDI:

4953170340086

Quantity: 395 units US; 165 units OUS

Product: EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-Q190

Model / REF:

BF-Q190

Serial Numbers:

All Serial No.

UDI:

4953170434792

4953170335198

Quantity: 916 units US; 1,402 units OUS

Product: BRONCHOFIBERSCOPE OLYMPUS BF TYPE TE2

Model / REF:

BF-TE2

Serial Numbers:

All Serial No.

UDI:

4953170339998

Quantity: 1 unit US; 5,286 units OUS

Product: EVIS EXERA BRONCHOVIDEOSCOPE OLYMPUS BF TYPE XT160

Model / REF:

BF-XT160

Serial Numbers:

All Serial No.

UDI:

4953170340147

Quantity: 262 units US; 558 units OUS

Product: EVIS EXERA b BRONCHOVIDEOSCOPE OLYMPUS BF-XT190

Model / REF:

BF-XT190

Serial Numbers:

All Serial No.

UDI:

4953170402470

Quantity: 361 units US; 258 units OUS

Product: OES BRONCHOFIBERSCOPE OLYMPUS BF TYPE XT40

Model / REF:

BF-XT40

Serial Numbers:

All Serial No.

Quantity: 116 units US; 705 units OUS

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97441

Status: Active

Manufacturer: Olympus Corporation of the Americas

Sold By: Hospital supply distributors; Direct sales to medical facilities

Manufactured In: United States

Distributed To: Nationwide