Device recall
Z-1535-2026: GEM Premier 5000; Part No. 00055415010.
FDA device recall · Class II · Instrumentation Laboratory
Key facts
| Recall number (Z-number) | Z-1535-2026 |
|---|---|
| Recall event | 98349 |
| Product | GEM Premier 5000; Part No. 00055415010. |
| Product code | CHL |
| Recalling firm | Instrumentation Laboratory |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K160412 |
| FEI number | 1217183 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 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