SUNSTAR G — Class II medical device recall Z-1182-2021
Terminated recall by Sunstar Americas, Inc., reported 2021-03-17, distributed nationwide. The product may be contaminated with Burkholderia cepacia
| Recall number | Z-1182-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sunstar Americas, Inc., Schaumburg, IL, United States |
| Recall initiated | 2021-02-18 |
| Classified | 2021-03-05 |
| Reported by FDA | 2021-03-17 |
| Terminated | 2024-09-30 |
| Distributed | Nationwide (US) |
| Quantity | 56,960 bottles |
| Pathogens | burkholderia |
| UPC / GTIN / UDI-DI | 00070942307130 |
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
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-1182-2021. 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.