Medtronic Recalls McGRATH X3 Disposable Laryngoscope Blades Due to Fit Issues
Medtronic is recalling McGRATH X3 Disposable Laryngoscope Blades because they may not fit the video laryngoscope handle or fit too tightly, potentially affecting optical performance.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect (fit/optical performance) without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Medtronic, PLC is recalling McGRATH X3 Disposable Laryngoscope Blades, which are used with the McGRATH MAC Video Laryngoscope to aid in the intubation of the trachea. The recall involves 109,897 units distributed worldwide, including the United States, Australia, Canada, and numerous other countries.
The recall was initiated because the blades do not fit the McGRATH MAC video laryngoscope handle or were tight fitting on the handles. This issue may result in a change in optical performance as displayed on the video screen. The affected product codes are X3-002-000 (Individual Unit) and X3-003-000 (Carton of 10 Units).
Healthcare facilities and users should stop using the affected blades and contact Medtronic for further instructions. The specific lot numbers affected are M1811191, M1811261, M1812071, M1812271, M1901081, M1901161, M1902251, M1903131, M1904031, M1904241, M1906031, and M1906121.
The recalled product
- Product
- 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…
- Manufacturer
- Medtronic, PLC
- Affected units
- 109,897
Distribution
Distributed nationwide across the United States.
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