Device recall
Z-0998-2024: Sperm separation media are used to separate motile sperm from other constituents…
FDA device recall · Class II · Fujifilm Irvine Scientific, Inc.
Key facts
| Recall number (Z-number) | Z-0998-2024 |
|---|---|
| Recall event | 93726 |
| Product | Sperm separation media are used to separate motile sperm from other constituents of semen. |
| Product code | MQL |
| Recalling firm | Fujifilm Irvine Scientific, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K991341 |
| FEI number | 2022379 |
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