Covidien McGRATH MAC Video Laryngoscope Instruction Update for Battery Handling
Covidien is recalling the McGRATH MAC Video Laryngoscope to address battery handling information in its instructions. The recall affects devices distributed worldwide.
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: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The issue involves instructional information that requires clarification, with no evidence of actual device malfunction or patient harm. Per the severity rubric, voluntary precautionary recalls without reported incidents are classified as Moderate.
Plain-English summary
Covidien is recalling the McGRATH MAC Video Laryngoscope (REF: 301-000-000, Non-Sterile, RxOnly) due to a required update to the device's Instructions for Use (IFU).
The manufacturer has determined that the IFU requires an update to address battery handling information. No illnesses or injuries related to this issue have been reported.
Approximately 68,093 devices have been distributed worldwide, including across all U.S. states, Puerto Rico, the U.S. Virgin Islands, and more than 100 countries internationally. Healthcare providers and device users should contact Covidien for updated instructions once available and ensure all device operators are informed of the revised battery handling procedures.
The recalled product
- Product
- Covideien McGRATH MAC Video Laryngoscope, REF: 301-000-000, Non-Sterile, RxOnly
- Manufacturer
- Covidien
- Hazard
- Affected units
- 68,093
Distribution
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