Class II — SunMed Holdings, LLC
| Recalling firm | SunMed Group Holdings, LLC dba AirLife |
|---|---|
| Registered facility | View this company's 7 registered facilities → (openFDA recall records do not name a specific facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | 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. |
| 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 |
| Quantity | 43,290 (Eaches) |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA. |
| Initiated | 2022-12-22 |
| Classified | 2023-01-26 |
| Recall number | Z-1020-2023 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — SunMed Holdings, LLC (Z-1020-2023).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/91391/
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