# FDA recall Z-1019-2023

> **SunMed Holdings, LLC** · Class II · device recall initiated 2022-12-22.

## 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.

## Distribution

US Nationwide distribution in the states of AL, CA, FL, MI, OH, TN, TX, WA.

## Key facts

- **Recall number:** Z-1019-2023
- **Recalling firm:** SunMed Holdings, LLC
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2022-12-22
- **Report date:** 2023-02-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Grand Rapids, MI, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1019-2023

## Citation

> AI Analytics. FDA recall Z-1019-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-1019-2023. Source: US FDA. Licensed CC0.

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