Device recall
Z-0004-2021: Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item…
FDA device recall · Class II · Covidien, LP
Key facts
| Recall number (Z-number) | Z-0004-2021 |
|---|---|
| Recall event | 86214 |
| Product | Endo GIA Auto Suture Universal Articulating Loading Unit 45 mm - 2.0 mm, Item Code 030453 - Product Usage: The Endo GIA universal staplers have applications in abdominal, gynecologic, pediatric and thoracic surgery for resection, transection and creation of anastomosis. |
| Product code | GDW |
| Recalling firm | Covidien, LP |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K111825 |
| FEI number | 1219930 |
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