FDA Device recall Z-0600-2024
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal…
- FDA Device
- Class I
- ongoing
- Published 2024-01-03
On 2024-01-03 the FDA classified a Class I recall of Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal… by Megadyne Medical Products, citing affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requ….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0600-2024 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-12-08 |
| Published | 2024-01-03 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Megadyne Medical Products |
| Distribution | US |
Product
Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
Reason
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.
Identifiers
| code_info | UDI-DI 10614559104859 All units within expiry |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0600-2024%22
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