FDA Device recall Z-1182-2021
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 wat…
- FDA Device
- Class II
- terminated
- Published 2021-03-17
On 2021-03-17 the FDA classified a Class II recall of 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 wat… by Sunstar Americas, citing the product may be contaminated with Burkholderia cepacia.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1182-2021 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-02-18 |
| Published | 2021-03-17 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Sunstar Americas |
| Distribution | US |
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
The product may be contaminated with Burkholderia cepacia
Identifiers
| upc | 070942307130 |
|---|---|
| code_info | All lot codes within expiry |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1182-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.