FDA recall Z-2001-2023
Megadyne Medical Products, Inc. · Class I · device
Product
MEGADYNE MEGA SOFT Universal 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-2001-2023