FDA Device recall Z-1994-2023
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
- FDA Device
- Class I
- ongoing
- Published 2023-07-05
On 2023-07-05 the FDA classified a Class I recall of MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery by Megadyne Medical Products, citing firm has received reports of patient burns in surgical procedures where device was used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1994-2023 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2023-06-01 |
| Published | 2023-07-05 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Megadyne Medical Products |
| Distribution | US |
Product
MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Reason
Firm has received reports of patient burns in surgical procedures where device was used.
Identifiers
| code_info | Model No. 0800; UDI-DI: 10614559100936; All Units. |
|---|
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-1994-2023%22
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