Device recall
Z-2522-2023: Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be…
FDA device recall · Class II · Aomori Olympus Co., Ltd.
Key facts
| Recall number (Z-number) | Z-2522-2023 |
|---|---|
| Recall event | 92784 |
| Product | Olympus Distal Attachment (in Olympus Disposable EMR Kit)- Designed to be attached to the distal end of the endoscope. Disposable EMR Kit: K-001, K-002, K-003, K-004, K-011, K-012 |
| Product code | FDS |
| Recalling firm | Aomori Olympus Co., Ltd. |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K984358 |
| FEI number | 3003995201 |
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