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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/Monitoring Devices

Neurovision Medical Products Inc: Cobra EMG ET Tube Recalled for Incorrect Size Labeling

Agency Publication Date: August 23, 2024
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Summary

Neurovision Medical Products Inc. is recalling 5 boxes (containing 25 single kits) of its Cobra 3-Plate EMG ET Tube (6.0mm). These medical kits were mislabeled, meaning the packaging contains a tube size different than what is indicated on the label. This recall affects sterile kits distributed nationwide across the United States. No injuries or incidents have been reported to date, but the use of an incorrectly sized breathing tube can lead to surgical delays or complications.

Risk

The labeling indicates a 6.0mm tube size when the kit contains a different size. If a medical provider attempts to use an incorrectly sized endotracheal tube, it may not fit the patient's airway properly, potentially leading to inadequate ventilation, airway trauma, or delays in critical monitoring during surgery.

What You Should Do

  1. Check your inventory for the Cobra, 3-Plate EMG ET Tube, 6.0mm (REF: LTE7003PM) with Lot Number 051724B and UDI B006LTE7003PS52.
  2. Verify if the tube size inside the kit matches the 6.0mm size specified on the exterior labeling before any surgical use.
  3. Immediately stop using any kits identified with Lot Number 051724B.
  4. Contact your healthcare provider or Neurovision Medical Products Inc at 353 San Jon Rd, Ventura, California, 93001-3250, for instructions on how to return affected kits and receive replacements.
  5. For further questions or to report a problem, 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 coordination

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

Affected Products

Product: Cobra, 3-Plate EMG ET Tube, 6.0mm
Model / REF:
REF: LTE7003PM
UDI: B006LTE7003PS52
Lot Numbers:
051724B

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94931
Status: Active
Manufacturer: Neurovision Medical Products Inc
Sold By: Direct distribution
Manufactured In: United States
Units Affected: 5 BOXES (25 single kits)
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 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.