Device recall
Z-1855-2026: Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and…
FDA device recall · Class I · Intuitive Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-1855-2026 |
|---|---|
| Recall event | 98525 |
| Product | Intuitive 8 mm SureForm 30 Gray Reloads Reference Numbers: 48230M-05 and 48230M-06 |
| Product code | NAY |
| Recalling firm | Intuitive Surgical, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K211997, K222839, K241638 |
| FEI number | 3001675293 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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