Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device
SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling discrepancy between the device labeling and Instructions For Use. No adverse events have been reported. The issue is a documentation and labeling error with a documented practical workaround, consistent with the 'minor labeling errors' and 'precautionary recall' criterion for Moderate severity.
Plain-English summary
The Air-Q3 intubating laryngeal airway (ILA) is being recalled due to a discrepancy between the labeling in the Instructions For Use (IFU) and the printed text on the device regarding orogastric (OG) tube sizes. This mismatch could create confusion when clinicians attempt to place a gastric catheter through the device channels.
Approximately 43,290 units have been distributed nationwide across Alabama, California, Florida, Michigan, Ohio, Tennessee, Texas, and Washington. All lot numbers are affected, spanning device sizes from 0.0 to 4.0.
If a clinician is unable to pass a gastric catheter through one of the device channels, a smaller-diameter gastric catheter can be used. SunMed Holdings, LLC is the manufacturer recalling the product.
The recalled product
- Product
- Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
- Manufacturer
- SunMed Holdings, LLC
- Affected units
- 43,290
Distribution
Part of a larger recall action
This product is one of 2 recalled by SunMed Holdings, LLC 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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