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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Olympus Corporation of the Americas: Olympus Bronchoscopes and Mobilescopes Recalled for Choking and Lodging Risks

Agency Publication Date: August 31, 2023
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Summary

Olympus is recalling approximately 41,838 bronchoscopes and airway mobilescopes across multiple model lines because the device diameter may be too large for standard endotracheal tube connectors. This manufacturing defect can cause the scope to become lodged or stuck inside a patient's breathing tube during critical medical procedures. The recall affects a wide range of models including the BF, MAF, and LF series distributed nationwide. Because these are professional medical devices, consumers should contact their healthcare provider or the manufacturer for specific guidance on affected units.

Risk

The endoscope can become physically stuck within the endotracheal tube connector, which may obstruct a patient's airway or delay essential medical treatment, potentially leading to serious respiratory distress or injury.

What You Should Do

  1. Identify if your facility uses Olympus Bronchovideoscope, Airway Mobilescope, or Tracheal Intubation Fiberscope models by checking the model number and UDI-DI on the device or packaging.
  2. Check for affected models including BF-1T150, BF-1T180, BF-H190, BF-Q190, MAF-GM, MAF-TM, LF-TP, and several others listed in the product details.
  3. Match your device against the specific UDI-DI codes provided, such as 04953170308185, 04953170340048, 04953170340086, or 04953170335181, which cover all serial numbers for these models.
  4. Contact your healthcare provider or Olympus Corporation of the Americas at 3500 Corporate Pkwy, Center Valley, PA 18034 for further instructions and information regarding the lodged device risk.
  5. Report any incidents of devices becoming lodged or stuck to Olympus and the FDA's MedWatch program.
  6. For additional questions, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer notification and guidance

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Olympus Bronchovideoscope, Models BF-1T150, BF-1T60, BF-MP60, BF-P150, BF-P60, BF-PE2, BF-TE2, BF-XT160
Model / REF:
BF-1T150
BF-1T60
BF-MP60
BF-P150
BF-P60
BF-PE2
BF-TE2
BF-XT160
UPC Codes:
04953170308185
04953170288968
04953170308161
04953170339264
04953170308277
04953170339394
04953170308178
04953170288876
04953170308123
04953170339196
04953170062988
04953170339974
04953170063008
04953170339998
0495317040147
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-MP160F, BF-XP160F, BF-XP60
Model / REF:
BF-MP160F
BF-XP160F
BF-XP60
UPC Codes:
04953170340048
04953170289064
04953170340093
04953170289033
04953170340116
04953170308154
04953170339240
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Model BF-Q180-AC
Model / REF:
BF-Q180-AC
UPC Codes:
04953170340086
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-1T180, BF-1TQ180, BF-P180, & BF-Q180
Model / REF:
BF-1T180
BF-1TQ180
BF-P180
BF-Q180
UPC Codes:
04953170308215
04953170288975
04953170339325
04953170308222
04953170289002
04953170339349
04953170308192
04953170317965
04953170339288
04953170288883
04953170308208
04953170288937
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-UC180F & BF-UC190F
Model / REF:
BF-UC180F
BF-UC190F
UPC Codes:
04953170356360
04953170399831
Lot Numbers:
All Serial Numbers
Product: Olympus Airway Mobilescope, Models MAF-GM & MAF-TM
Model / REF:
MAF-GM
MAF-TM
UPC Codes:
04953170340369
04953170288661
04953170288630
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-1TH190, BF-H190, BF-Q170, & BF-Q190
Model / REF:
BF-1TH190
BF-H190
BF-Q170
BF-Q190
UPC Codes:
04953170335181
04953170434778
04953170335174
04953170434754
04953170342912
04953170335198
04953170434792
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-MP190F
Model / REF:
BF-MP190F
UPC Codes:
04953170395581
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-XT190
Model / REF:
BF-XT190
UPC Codes:
04953170402470
Lot Numbers:
All Serial Numbers
Product: Olympus Airway Mobilescope, Models MAF-DM2, MAF-GM2, & MAF-TM2
Model / REF:
MAF-DM2
MAF-GM2
MAF-TM2
UPC Codes:
04953170407260
04953170407208
04953170407147
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-P190 & BF-XP190
Model / REF:
BF-P190
BF-XP190
UPC Codes:
04953170342110
04953170434983
04953170342134
04953170434990
Lot Numbers:
All Serial Numbers
Product: Olympus Tracheal Intubation Fiberscope, Models LF-P & LF-V
Model / REF:
LF-P
LF-V
UPC Codes:
04953170051098
04953170452932
04953170156250
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-3C40 & BF-N20
Model / REF:
BF-3C40
BF-N20
UPC Codes:
04953170308130
04953170339219
04953170051142
04953170442667
Lot Numbers:
All Serial Numbers
Product: Olympus Bronchovideoscope, Models BF-3C160
Model / REF:
BF-3C160
UPC Codes:
0495317034031
04953170063039
Lot Numbers:
All Serial Numbers
Product: Olympus Tracheal Intubation Fiberscope, Models LF-DP, LF-GP, & LF-TP
Model / REF:
LF-DP
LF-GP
LF-TP
UPC Codes:
04953170136856
04953170340192
04953170061998
04953170340215
04953170317576
04953170136825
Lot Numbers:
All Serial Numbers

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92779
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Authorized Medical Distributors; Direct Hospital Sales
Manufactured In: United States
Units Affected: 15 products (1715 units; 1072 units; 416 units; 3652 units; 4115 units; 1859 units; 9449 units; 441 units; 235 units; 122 units; 3949 units; 2127 units; 881 units; 1004 units; 10801 units)
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.

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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 ยท 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.