FDAFDA · Food and drugs·Recall number Z-1999-2023
MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Published July 5, 2023 · Recall initiated: June 1, 2023
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Firm has received reports of patient burns in surgical procedures where device was used.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Megadyne Medical Products, Inc.
- Distributor
- Distributed US Nationwide.
- Lot
- Model No. 0847; UDI-DI: 10614559104842; All Units.
- Risk classification
- Class I
- Area (FDA)
- device
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.