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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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Critical RiskFDA Device
Medical Devices/Surgical Equipment

Covidien: McGRATH MAC Video Laryngoscopes Recalled Due to Defective Stolen Units

Agency Publication Date: November 2, 2023
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Summary

Covidien is recalling approximately 5,709 McGRATH MAC Video Laryngoscopes because these specific units were stolen after failing quality tests and being designated for destruction. These defective devices were subsequently sold and distributed illegally, and they may lack proper packaging, labeling, or serial numbers. Using these failed devices in a medical setting can result in a failed laryngoscopy or intubation, which are critical procedures for maintaining a patient's airway.

Risk

The use of these defective laryngoscopes may lead to an inability to see the vocal cords or successfully place a breathing tube. This can result in respiratory failure, low oxygen levels, or other life-threatening complications during emergency or surgical procedures.

What You Should Do

  1. Immediately check the serial number on your McGRATH MAC Video Laryngoscope (REF: 301-000-000) against the list of over 500 affected numbers, such as 000063, 100010, 110066, and 130462.
  2. Look for identifying signs of stolen units, including missing serial numbers on the device or packaging that appears non-standard or incomplete.
  3. Stop using any device identified as part of this recall immediately to avoid patient injury.
  4. If you possess an affected device, set it aside and do not use it for medical procedures.
  5. Contact your healthcare provider or Covidien/Medtronic at 1-888-463-6332 for further instructions on how to handle or return the defective units.
  6. Report any adverse events or quality problems experienced with the use of this product to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.
  7. For additional questions, contact the FDA hotline at 1-888-463-6332 (1-888-INFO-FDA).

Your Remedy Options

📋Other Action

Quarantine and identify affected units.

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

Affected Products

Product: Stolen McGRATH MAC Video Laryngoscopes
Model / REF:
REF: 301-000-000
UDI-DI: 10884521776494
20884521823393
Lot Numbers (1652):
000063
000076
000085
000092
000093
000112
000120
000121
000146
000153
000154
000155
000166
000179
000190
000197
000202
000224
000233
000238
000255
000308
000329
000375
000389
000436
000446
000455
000464
000465
000497
000512
000526
000528
000546
000553
000597
000607
000628
000641
000648
000650
000673
000677
000745
000752
000753
000760
000764
000769

Product Images

Image 1: “Covidien McGRATH MAC Video Laryngoscope device”

Image 1: “Covidien McGRATH MAC Video Laryngoscope device”

Image 2: “McGRATH MAC Video Laryngoscope device”

Image 2: “McGRATH MAC Video Laryngoscope device”

Image 3: “Covidien McGRATH MAC Video Laryngoscope device container”

Image 3: “Covidien McGRATH MAC Video Laryngoscope device container”

Image 4: “McGRATH MAC Video Laryngoscope device container”

Image 4: “McGRATH MAC Video Laryngoscope device container”

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 93002
Status: Active
Manufacturer: Covidien
Sold By: Unknown
Manufactured In: United States
Units Affected: 5709
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 · FDA Press Release · 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.