Megadyne Patient Return Electrode Recalled Due to Serious Burn Injury Reports
Megadyne Medical Products is recalling the MEGA SOFT Universal Plus Patient Return Electrode due to reports of serious burn injuries, including third-degree burns. The device should not be used in patients under 12 years old.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: FDA Class I recall with documented reports of serious patient burn injuries, including third-degree burns requiring medical intervention and resulting in prolonged hospitalizations, scarring, and additional surgeries. FDA Class I classification satisfies the Critical severity criterion.
Plain-English summary
The Megadyne MEGA SOFT Universal Plus Dual Patient Return Electrode (Product Code 0848) is a reusable electrode used in electrosurgical procedures, manufactured by Megadyne Medical Products, Inc.
Megadyne has received reports of patient burn injuries, including third-degree burns, in both pediatric and adult patients. These injuries required medical intervention and may result in prolonged hospitalizations, scarring, and additional surgeries.
In response to these injury reports, the manufacturer has restricted use of the affected product to patients age 12 years and older. The device has been distributed worldwide, including throughout the United States, Puerto Rico, and multiple international markets.
The recalled product
- Product
- Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
- Manufacturer
- Megadyne Medical Products, Inc.
- Category
- Medical Device — Electrosurgery
- Hazard
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 (1)
- UDI-DI 10614559104859 All units within expiry
Distribution
Part of a larger recall action
This product is one of 4 recalled by Megadyne Medical Products, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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