Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Recalled by SunMed Holdings, LLC Due to There is an orogastric (OG) tube size discrepancy...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SunMed Holdings, LLC directly.
Affected Products
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
Quantity: 43,290 (Eaches)
Why Was This Recalled?
There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the device. If the clinician is unable to pass a gastric catheter through one of the channels, the clinician may use a smaller-diameter gastric catheter.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SunMed Holdings, LLC
SunMed Holdings, LLC has 18 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report