Device recall
Z-1539-2010: AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R…
FDA device recall · Class II · Encision, Inc.
Key facts
| Recall number (Z-number) | Z-1539-2010 |
|---|---|
| Recall event | 55286 |
| Product | AEM Disposable Electrode, Spatula, 35cm, REF ES0301, Qty: 10 each Sterile R, Manufactured for: Encision Inc., Boulder, CO 80301, made in Taiwan. Electrosurgical accessories intended, by use of monopolar high-frequency electrical current from compatible electrosurgical generators, for ablation… |
| Product code | GEI |
| Recalling firm | Encision, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 21, 2010 |
| 510(k) numbers | K091074 |
| FEI number | 1000117361 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 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