Megadyne Patient Return Electrodes Recalled Due to Serious Burn Risk
Megadyne Medical Products recalls its MEGA SOFT Universal Dual Patient Return Electrode due to reports of severe burn injuries, including third-degree burns requiring medical intervention. Use is now restricted to patients age 12 and older.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I recall with reported serious injuries (third-degree burns requiring medical intervention), meeting the rubric criterion for Severe classification. No fatalities were reported, which prevents a Critical rating.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGA SOFT Universal Dual Patient Return Electrode (Product Code 0846), a reusable electrosurgical device. Approximately 3,572 units have been distributed worldwide, with distribution in the United States, Puerto Rico, and 50 other countries.
The manufacturer has received reports of patient burn injuries associated with the device, including third-degree burns that required medical intervention. These injuries may result in prolonged hospital stays, scarring, and additional surgeries. The FDA has classified this as a Class I recall.
Due to the burn risk, Megadyne has restricted use of this product to patients age 12 years and older. Healthcare providers and patients who have this device should contact Megadyne Medical Products, Inc. if they have questions. All recalled units remain within their expiration dates.
The recalled product
- Product
- Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
- Manufacturer
- Megadyne Medical Products, Inc.
- Affected units
- 3,572
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 10614559104248 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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