The Recall Desk
SevereFDA (Devices)·Z-2001-2023·Announced 2023-07-05

Megadyne Mega Soft Universal Patient Return Electrode Recalled for Burn Risk

Megadyne Medical Products is recalling 21,100 MEGA SOFT electrosurgery patient return electrodes distributed nationwide due to reports of patient burns during surgical procedures.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is a Class I FDA medical device recall with reported patient burns. FDA Class I recalls represent serious hazards and mandate a minimum score of 4. The reported patient injuries confirm significant harm risk.

Plain-English summary

Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (Model No. 0846, UDI-DI: 10614559104248), a device used during electrosurgery. Approximately 21,100 units were distributed nationwide.

The firm has received reports of patient burns occurring during surgical procedures where this device was used.

Healthcare providers and facilities using this device should contact Megadyne Medical Products for further instructions regarding this recall.

The recalled product

Product
MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Manufacturer
Megadyne Medical Products, Inc.
Category
Medical Device — Electrosurgery Equipment
Hazard
  • burn-injury

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (3)

  • Model No. 0846
  • UDI-DI: 10614559104248
  • All Units.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category