Device recall
Z-1182-2021: SUNSTAR G.U.M. HYDRAL DRY MOUTH RELIEF On-the-go Oral Spray, 2 FL.OZ. UPC0 70942…
FDA device recall · Class II · Sunstar Americas, Inc.
Key facts
| Recall number (Z-number) | Z-1182-2021 |
|---|---|
| Recall event | 87371 |
| 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… |
| Product code | LFD |
| Recalling firm | Sunstar Americas, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2024 |
| 510(k) numbers | K181134 |
| FEI number | 1413787 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database