FDA recall Z-2000-2023

Product

MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery

Reason for recall

Firm has received reports of patient burns in surgical procedures where device was used.

Distribution

Distributed US Nationwide.

Key facts

Status

Ongoing

Initiation date

2023-06-01

Report date

2023-07-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Blue Ash, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2000-2023