FDA Device recall Z-2250-2024
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Ele…
- FDA Device
- Class I
- ongoing
- Published 2024-07-10
On 2024-07-10 the FDA classified a Class I recall of Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Ele… by Megadyne Medical Products, citing to limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2250-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2024-06-17 |
| Published | 2024-07-10 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Megadyne Medical Products |
| Distribution | US |
Product
Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
Reason
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Identifiers
| code_info | Product Code: 0835; UDI-DI: 10614559101872; Lot Number: All distributed lot numbers. Product code has been discontinued from future production. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2250-2024%22
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