Device recall
Z-2700-2020: InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-2700-2020 |
|---|---|
| Recall event | 85871 |
| Product | InnoWave Sonic Irrigator, There are currently six models (PCF, Pro, Ultra, Ultra+, Unity, and ECO) - Product Usage: STERIS InnoWave Sonic Irrigators are intended to thoroughly clean (remove tissue, blood, and other contaminants from) a variety of reusable surgical instruments. The equipment provides… |
| Product code | FLG |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 22, 2020 |
| FEI number | 1527821 |
At a glance
- None 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