Device recall
Z-0224-2023: ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal…
FDA device recall · Class II · Boston Scientific Corporation
Key facts
| Recall number (Z-number) | Z-0224-2023 |
|---|---|
| Recall event | 90986 |
| Product | ORISE Gel Submucosal Lifting Agent--Indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device Packaged as follows: UPN: (1)Twin… |
| Product code | PLL |
| Recalling firm | Boston Scientific Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K180068 |
| FEI number | 3005099803 |
At a glance
- 1–9 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