McGrath Mac 2 Laryngoscope Blade Recalled for Anti-Fog Agent Defect
Covidien is recalling McGrath Mac 2 disposable laryngoscope blades due to defective anti-fog coating that can cause condensation and vision obstruction. Approximately 42,367 units were distributed across the United States and internationally.
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: This FDA Class II recall involves a functional defect in a critical airway management device. While no injuries or illnesses have been reported and the hazard is theoretical, the risk-of-harm nature of a device used in intubation procedures—where visual clarity is essential—justifies a High severity rating.
Plain-English summary
Covidien is recalling McGrath Mac 2 disposable laryngoscope blades (model REF 350-017-000, Lot #22082207 and 22083101). These sterile, single-use medical devices are used during intubation and airway management in hospitals and surgical settings.
The anti-fog agent coating on these blades may not have been applied effectively, allowing condensation to accumulate on the viewing screen. This can result in blurred or obscured vision during use, potentially compromising the safety and effectiveness of the device.
Approximately 42,367 units were distributed throughout all U.S. states and to international locations including Australia, Austria, Belgium, Denmark, France, Germany, Hong Kong, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Spain, Sweden, Switzerland, and the United Arab Emirates. Healthcare providers using affected units should discontinue use and contact Covidien for replacement options. No injuries or illnesses related to this defect have been reported.
The recalled product
- Product
- McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
- Manufacturer
- Covidien
- Hazard
- vision-obstruction
- anti-fog-failure
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: 10884521816336/ Lot # 22082207 and 22083101
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
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