Device recall
Z-1034-2021: NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with…
FDA device recall · Class II · Aomori Olympus Co., Ltd.
Key facts
| Recall number (Z-number) | Z-1034-2021 |
|---|---|
| Recall event | 87074 |
| Product | NEEDLEMASTER 5MMx 21G UPPER, model no. NM-610L-0521 - Product Usage: Used with endoscopes to perform endoscopic vascular or submucosal injection in the GI tract. |
| Product code | FBK |
| Recalling firm | Aomori Olympus Co., Ltd. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 11, 2024 |
| 510(k) numbers | K153625 |
| FEI number | 3003995201 |
At a glance
- 1–9 Linked 510(k)s
- 100–999 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