Device recall
Z-2249-2024: Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name…
FDA device recall · Class I · Megadyne Medical Products, Inc.
Key facts
| Recall number (Z-number) | Z-2249-2024 |
|---|---|
| Recall event | 94837 |
| Product | Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over… |
| Product code | GEI |
| Recalling firm | Megadyne Medical Products, Inc. |
| Recall class | Class I |
| Status | Open, Classified |
| 510(k) numbers | K021077 |
| FEI number | 1721194 |
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