Device recall
Z-1687-2024: Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121…
FDA device recall · Class II · Electro Medical Systems SA
Key facts
| Recall number (Z-number) | Z-1687-2024 |
|---|---|
| Recall event | 94293 |
| Product | Brand Name: WATER BOTTLE Product Name: WATER BOTTLE Model/Catalog Number: EG-121 Software Version: N/A Product Description: These bottles are sold empty and are filled by the user with water fort dental treatments. The bottle is pressurized on the device during use. Component: YES. AIRFLOW… |
| Product code | ELC |
| Recalling firm | Electro Medical Systems SA |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K190124 |
| FEI number | 3002806910 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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