Device recall
Z-1859-2018: (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE…
FDA device recall · Class II · COVIDIEN MEDTRONIC
Key facts
| Recall number (Z-number) | Z-1859-2018 |
|---|---|
| Recall event | 79974 |
| Product | (1)BOX SLEEVEGK3 (2) BOX SLEEVEGK4 SLEEVE GASTRECTOMY (3)BOX SLEEVEJAWI SLEEVE GASTRECTOMY BOX (4) SSLEEVE ZEST DO SLEEVE GASTREKTOMIIX1 Product Usage: The Endo GIA universal and Endo GIA universal XL staplers place two, triple-staggered rows of titanium staples and simultaneously divides the tissue… |
| Product code | GDW |
| Recalling firm | COVIDIEN MEDTRONIC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 17, 2020 |
| 510(k) numbers | K111825 |
| FEI number | 1219930 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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