Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF… — Class II medical device recall Z-1019-2023
Ongoing recall by SunMed Holdings, LLC, reported 2023-02-01, distributed nationwide. There is an orogastric (OG) tube size discrepancy between the labeling in the IFU and the printed text on the
| Recall number | Z-1019-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SunMed Holdings, LLC, Grand Rapids, MI, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-01-26 |
| Reported by FDA | 2023-02-01 |
| Distributed | Nationwide (US) |
| Quantity | 43,290 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00814954020188, 00814954020195, 00814954020201, 00814954020218, 00814954020225, 00814954020232, 00814954020249, 10814954020185, 10814954020192, 10814954021007, 10814954021014, 10814954021021, 10814954021038, 10814954021045, 20814954020182, 20814954020199, 20814954020205, 20814954020212, 20814954020229, 20814954020236, 20814954020243 |
| Model numbers | 0.0, 0.5, 1.0, 1.5, 2.0, 3.0, 4.0, 50005, 50055, 50105, 50155, 50205, 50305, 50405 |
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
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1019-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.