The Recall Desk
HighFDA (Devices)·Z-0169-2024·Announced 2023-11-08

McGrath Mac 2 Disposable Laryngoscope Blades Recalled for Ineffective Anti-Fog Coating

Covidien recalled 42,367 McGrath Mac 2 disposable laryngoscope blades due to an ineffective anti-fog agent that may cause screen condensation and visual obstruction during intubation procedures.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II recall of a risk-of-harm medical device used in critical airway management. The ineffective anti-fog agent may cause visual obstruction during intubation, potentially impairing the provider's ability to safely manage the airway. No illnesses or injuries have been reported, keeping the score at 3 rather than 4.

Plain-English summary

Covidien has recalled 42,367 McGrath Mac 2 disposable laryngoscope blades (REF: 350-084-000, Lot # 22102001). These medical devices are used by healthcare providers to visualize the airway during intubation procedures.

The recalled blades contain an ineffectively applied anti-fog agent. This defect may result in condensation accumulating on the blade's screen, causing the view to become blurred or obscured during clinical use.

The affected units were distributed throughout the United States and internationally to countries including Australia, Austria, Belgium, France, Germany, Italy, Netherlands, New Zealand, Spain, Sweden, Switzerland, and others.

Healthcare facilities that have received these blades should stop using them and contact Covidien immediately. The FDA has classified this recall as Class II. For additional information, reference FDA recall number Z-0169-2024.

The recalled product

Product
McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only
Manufacturer
Covidien
Hazard
  • vision-obstruction
  • anti-fog-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI: 10884521824386/ Lot # 22102001

Distribution

Distributed in 38 states:

  • AK
  • AL
  • AR
  • AZ
  • CA
  • CO
  • CT
  • DE
  • FL
  • GA
  • IA
  • IL
  • IN
  • KS
  • LA
  • MA
  • MD
  • MI
  • MO
  • MT
  • NC
  • ND
  • NH
  • NJ
  • NM
  • NY
  • OH
  • OK
  • OR
  • PA
  • SD
  • TN
  • TX
  • UT
  • VA
  • WA
  • WI
  • WY