The Recall Desk
Agency classClass IOur severity:CriticalFDA (Devices)·Z-2636-2024·Announced 2024-08-28

McGrath Mac Video Laryngoscope battery depletion may cause thermal event and explosion

McGrath Mac Video Laryngoscope devices may experience battery management system failures causing batteries to deplete below design thresholds, potentially resulting in thermal events and explosions.

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 5/5 (Critical).

Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.

Our severity reasoning: FDA Class I classification applies. Class I recalls by definition indicate serious potential for injury or death. The defect—battery depletion leading to thermal events and explosion risk—poses a critical hazard during use of this essential airway management device.

Plain-English summary

McGrath Mac Video Laryngoscope (REF: 300-000-000, non-sterile, prescription-only) devices manufactured by Covidien are being recalled due to a defect in the battery management system. The affected devices may experience battery depletion below their design thresholds.

When battery depletion occurs below design specifications, the laryngoscope may experience a thermal event potentially followed by explosion. This hazard poses a serious risk during clinical use, particularly when the device is in active use near the patient during intubation procedures.

This recall affects approximately 75,544 units with worldwide distribution, including all U.S. states, territories, and numerous countries. Healthcare facilities using affected devices should immediately discontinue use and contact Covidien for device replacement or further instructions. Affected devices have serial numbers prior to 366170 or match the specific lot numbers listed in the official FDA recall notice.

The recalled product

Product
McGrath Mac Video Laryngoscope, REF: 300-000-000 , Non-Sterile, Rx Only
Manufacturer
Covidien
Category
Medical Device — Airway Management
Hazard
Affected units
75,544

Distribution

Distributed nationwide across the United States.

The notice also names 53 states specifically:

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.

See all 2 products in this recall →

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