McGRATH recallZ-1408-2020 · Medtronic, PLC · initiated Jan 28, 2020
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Medtronic, PLC or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles which may result in a change in optical performance as displayed on the video screen
FDA root cause category: Under Investigation by firm
What the company is doing
Medtronic issued Medical Device Correction letter via Federal Express and/or certified mail beginning January 28, 2020. The letter states reason for recall, health risk and action to take: dispose of affected product according to their institutions disposal procedures;" Notify all care environments about this notice in which the McGRATH" X3 disposable laryngoscope blades are used;" Promptly forward the information from the customer communication to any recipients to whom they have distributed any of the affected; product; Complete the acknowledgment and receipt form. Questions: Customer Service at (800) 448-3644, Option 2, Option 2.
Recall details
- Recall number
- Z-1408-2020
- Status
- Open, Classified
- Initiated by the company
- Jan 28, 2020
- Posted by the FDA
- Feb 10, 2020
- Recalling firm
- Medtronic, PLC
- Quantity
- 109,897
- Product code
- CCW
- Distribution
- Worldwide distribution - US Nationwide and countries Australia, Canada, New Zealand, India, Korea, Japan, Indonesia, Malaysia, Philippines, Singapore, Vietnam, Latin America, France, Switzerland. Italy, Belgium, Germany, Netherlands, Denmark, Poland, Austria, Czech Republic, Croatia, Spain, Finland,Greece, Guadeloupe, Ireland, Hungry, Italy, Jordan, Kazakhstan, Lithuania, Lebanon, Luxembourg, Norway, Poland, Portugal, Reunion, Romania, Russian Federation, Saudia Arabia, Sweden, Serbia, Slovakia, Turkey, Tunisia, United Arab Emirates, United Kingdom.
Product description
McGRATH X3 Disposable Laryngoscope Blades-used with the McGRATH MAC Video Laryngoscope to aid the intubation of the trachea Code: X3-002-000 (Individual Unit); X3-003-000 (Carton of 10 Units) - Product Usage: is a tool used to aid the intubation of the trachea. As a rigid laryngoscope it holds and shapes the anatomy allowing a clear view of the larynx and entrance to the trachea.
Code information (models, lots, serial numbers)
UDI: 15060272980082 Lot/Serial #: M1811191 M1811261 M1812071 M1812271 M1901081 M1901161 M1902251 M1903131 M1904031 M1904241 M1906031 M1906121
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- McGRATH X3-003-000Covidien LP · LARYNGOSCOPE, RIGID1 recall1 report
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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