# FDA recall Z-1182-2021

> **Sunstar Americas, Inc.** · Class II · device recall initiated 2021-02-18.

## Product

SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942 30713 0 - Product Usage: The device is formulated with water, moisturizers /humectants including one plant-based moisture rich humectant, sweeteners and flavors that collectively have lubricating, moisturizing, soothing, and refreshing properties to help relieve and manage the symptoms of dry mouth.

## Reason for recall

The product may be contaminated with Burkholderia cepacia

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-1182-2021
- **Recalling firm:** Sunstar Americas, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-02-18
- **Report date:** 2021-03-17
- **Termination date:** 2024-09-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Schaumburg, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1182-2021

## Citation

> AI Analytics. FDA recall Z-1182-2021. Retrieved 2026-07-26 from https://api.ai-analytics.org/recall/Z-1182-2021. Source: US FDA. Licensed CC0.

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