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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

SunMed Holdings, LLC: 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.

Agency Publication Date: January 26, 2023
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Affected Products

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

ALL LOTS Size REF UDI/DI 0.0 50005 Each: 00814954020188 Box: 10814954020185 Case: 20814954020182 0.5 50055 Each: 00814954020195 Box: 10814954020192 Case: 20814954020199 1.0 50105 Each: 00814954020201 Box: 10814954021007 Case: 20814954020205 1.5 50155 Each: 00814954020218 Box: 10814954021014 Case: 20814954020212 2.0 50205 Each: 00814954020225 Box: 10814954021021 Case: 20814954020229 3.0 50305 Each: 00814954020232 Box: 10814954021038 Case: 20814954020236 4.0 50405 Each: 00814954020249 Box: 10814954021045 Case: 20814954020243

Product: 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

ALL LOTS Size REF UDI/DI 0.0 60005 Each: 00814954020263 Box: 10814954020260 Case: 20814954020267 0.5 60055 Each: 00814954020270 Box: 10814954020277 Case: 20814954020274 1.0 60105 Each: 00814954020287 Box: 10814954021083 Case: 20814954020281 1.5 60155 Each: 00814954020294 Box: 10814954021090 Case: 20814954020298 2.0 60205 Each: 00814954020300 Box: 10814954021106 Case: 20814954020304 3.0 60305 Each: 00814954020317 Box: 10814954021113 Case: 20814954020311 4.0 60405 Each: 00814954020324 Box: 10814954021120 Case: 20814954020328

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 91391
Status: Active
Manufacturer: SunMed Holdings, LLC
Manufactured In: United States
Units Affected: 2 products (43,290 (Eaches))

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.