McGRATH MAC EMS Video Laryngoscope Battery Management System Recall
Covidien is recalling McGRATH MAC EMS Video Laryngoscopes due to a battery management system defect that may deplete below design specifications, creating risk of thermal events and explosion. About 10,449 units were distributed worldwide.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA classified this device recall as Class I, the highest classification for medical devices, requiring a minimum severity score of 4. The hazard—battery depletion causing thermal events and explosion risk—presents potential for serious injury, though no illnesses or injuries have been reported.
Plain-English summary
Covidien is recalling the McGRATH MAC EMS Video Laryngoscope (REF: 300-200-000, Non-Sterile, Rx Only) due to a potential defect in the device's battery management system.
The battery management system within affected devices may deplete below the design threshold, which may result in thermal events followed by risk of explosion during use.
Approximately 10,449 units were distributed worldwide, including throughout the United States and to numerous countries. The affected devices can be identified by the specific serial numbers and lot numbers provided in the FDA recall notification Z-2637-2024.
The recalled product
- Product
- McGRATH" MAC EMS Video Laryngoscope, REF: 300-200-000 , Non-Sterile, Rx Only
- Manufacturer
- Covidien
- Affected units
- 10,449
Distribution
Part of a larger recall action
This product is one of 2 recalled by Covidien under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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