MEGADYNE MEGA SOFT Return Electrode Recalled Due to Reported Patient Burn Injuries
Megadyne Medical Products is recalling its MEGA SOFT Universal Patient Return Electrode due to reports of patient burn injuries, including third-degree burns requiring intervention. The product is now limited to use in 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 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: This is an FDA Class I recall with reported serious patient injuries including third-degree burns requiring medical intervention, with potential for prolonged hospitalization, scarring, and additional surgeries. The Class I designation combined with documented injury reports meets the Critical criteria.
Plain-English summary
Megadyne Medical Products is recalling the MEGA SOFT Universal Patient Return Electrode (Product Code 0845), a reusable medical device used in electrosurgery. The recall affects approximately 9,587 units distributed worldwide, including the United States and multiple international locations.
The FDA has classified this as a Class I recall. Megadyne has received reports of patient burn injuries, including third-degree burns requiring medical intervention. These injuries may result in prolonged hospital stays, scarring, and the need for additional surgeries.
The product was previously used in both pediatric and adult patients. As of this recall, the affected electrodes are now restricted for use only in patients age 12 years and older.
Healthcare facilities and practitioners currently using this device should review the recall notification and follow Megadyne's guidance for the affected units.
The recalled product
- Product
- Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
- Manufacturer
- Megadyne Medical Products, Inc.
- Category
- Medical Device
- Affected units
- 9,587
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 10614559103906 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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