The Recall Desk
SevereFDA (Devices)·Z-1998-2023·Announced 2023-07-05

Patient Return Electrode Recalled Due to Burn Reports During Surgery

Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.

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 recalls have a minimum severity score of 4. The firm reported patient burns during surgical use, which are significant injury reports that support a Severe classification.

Plain-English summary

Megadyne Medical Products, Inc. is recalling the MEGA SOFT Universal Patient Return Electrode (Model No. 0845, UDI-DI: 10614559103906), which is used as a grounding component during electrosurgery procedures.

The FDA has classified this recall as Class I because the company has received reports of patient burns occurring during surgical procedures involving use of this device.

Approximately 21,100 units were distributed to healthcare facilities across the United States. Patients who have undergone surgery using this electrode should contact their healthcare provider if they experienced unexpected burns or skin injuries. Healthcare providers should immediately remove the affected device from clinical use.

The recalled product

Product
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Manufacturer
Megadyne Medical Products, Inc.
Category
Medical Device — Surgical / Electrosurgery
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. 0845
  • UDI-DI: 10614559103906
  • All Units.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category