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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: Fiberscopes Recalled for Inadequate Suction Flow Rate Performance

Agency Publication Date: December 14, 2023
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Summary

Olympus has recalled 75 units of the Tracheal Intubation Fiberscope (Model LF-GP) because there is insufficient data to prove the devices meet suction flow rate specifications. This means the device may not provide enough suction during a procedure to clear a patient's airway as intended. Consumers should contact their healthcare provider or Olympus directly for further instructions regarding these specific medical devices.

Risk

If the suction flow rate is lower than specified, medical professionals may not be able to effectively clear fluids or debris from a patient's airway during intubation, potentially leading to respiratory complications or delays in treatment.

What You Should Do

  1. Identify if you have the affected Tracheal Intubation Fiberscope (Model LF-GP) by checking the serial number and UDI-DI on the device or its packaging.
  2. Check for the following specific serial numbers: 2515143, 2515181, 2515449, 2515549, 2615760, 2615761, 2615763, 2615825, 2615830, 2615831, 2616057, 2616130, 2616199, 2716417, 2817430, 2917855, 2917867, 2917997, 2918003, 2918010, 2918012, 2918030, 2018337, 2018435, 2018486, 2018543, 2018571, 2018675, 2319768, 2319820, 2510582, or 2621001.
  3. Verify if your device matches UDI-DI 04953170340215 or 04953170061998.
  4. Contact Olympus Corporation of the Americas at their Pennsylvania headquarters or your clinical engineering department to determine the specific corrective actions required for these units.
  5. If you are a patient who has undergone a procedure involving this device and have concerns, contact your healthcare provider immediately.
  6. For further questions regarding this recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Inadequate performance data for suction flow rate

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

Affected Products

Product: TRACHEAL INTUBATION FIBERSCOPE OLYMPUS LF-GP
Model / REF:
LF-GP
UPC Codes:
04953170340215
04953170061998
Lot Numbers:
2515143
2515181
2515449
2515549
2615760
2615761
2615763
2615825
2615830
2615831
2616057
2616130
2616199
2716417
2817430
2917855
2917867
2917997
2918003
2918010
2918012
2918030
2018337
2018435
2018486
2018543
2018571
2018675
2319768
2319820
2510582
2621001

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93433
Status: Active
Manufacturer: Olympus Corporation of the Americas
Sold By: Olympus Corporation of the Americas; Authorized Medical Distributors
Manufactured In: United States
Units Affected: 75
Distributed To: Alaska, Alabama, Arizona, California, Georgia, Illinois, Indiana, Massachusetts, Maryland, Michigan, North Carolina, New Jersey, Ohio, Texas, Utah, Virginia, Washington, West Virginia

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 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.