The Recall Desk
SevereFDA (Devices)·Z-1996-2023·Announced 2023-07-05

MEGADYNE MEGA SOFT Patient Return Electrode Recalled for Reported Patient Burns

Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode used in electrosurgery 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: FDA Class I classification with reported patient injuries (burns) in surgical procedures. Per FDA criteria, Class I recalls with injury reports warrant a Severe classification.

Plain-English summary

Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode (Model No. 0835; UDI-DI: 10614559101872) used during electrosurgery. This recall affects 21,100 units distributed nationwide in the United States.

The recall was initiated due to reports of patient burns occurring in surgical procedures where the device was used.

Patients who underwent surgical procedures using this device and healthcare facilities using this equipment should be aware of this recall. Anyone experiencing complications related to this device should consult their healthcare provider.

For more information, contact Megadyne Medical Products, Inc. directly. Any adverse events or concerns related to this device can be reported to the FDA.

The recalled product

Product
MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
Manufacturer
Megadyne Medical Products, Inc.
Category
Medical Device — Surgical 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. 0835
  • UDI-DI: 10614559101872
  • All Units.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category