The Recall Desk
SevereFDA (Devices)·Z-1997-2023·Announced 2023-07-05

Pediatric Patient Return Electrode Recalled for Reported Burns in Surgery

Megadyne Medical Products recalls approximately 21,100 MEGADYNE MEGA SOFT Pediatric Patient Return Electrodes (Model 0840) due to reports of patient burns during electrosurgical 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 recall with confirmed reports of patient burns during use. Although specific hospitalization data is not provided in the source, the Class I designation and reported injuries meet the criteria for Severe severity.

Plain-English summary

The MEGADYNE MEGA SOFT Pediatric Patient Return Electrode (Model No. 0840) is being recalled by manufacturer Megadyne Medical Products, Inc. This device is used to return electrical current from patients during electrosurgical procedures. Approximately 21,100 units have been distributed nationwide.

The FDA issued a Class I recall after the firm received reports of patient burns occurring during surgical procedures in which the device was used. The recall affects all units of this model.

Healthcare facilities should consult FDA recall notice Z-1997-2023 for additional information regarding this recall.

The recalled product

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

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. 0840
  • UDI-DI: 10614559103395
  • All Units.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category