The Recall Desk
SevereFDA (Devices)·Z-2637-2024·Announced 2024-08-28

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.

What this means for you

Illness, injury, or structural failure has been reported. 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
Hazard
  • battery-depletion
  • thermal-event
  • explosion

Distribution

Distributed nationwide across the United States.