Megadyne MEGA SOFT Return Electrode Recalled for Serious Burn Injuries
Megadyne Medical Products is recalling approximately 2,312 MEGA SOFT Universal Plus Patient Return Electrodes due to reports of serious patient burn injuries, including third-degree burns. The product 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 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 classified as Critical due to the FDA Class I designation combined with reports of serious patient burn injuries, including third-degree burns requiring medical intervention and hospitalization.
Plain-English summary
Megadyne Medical Products, Inc. is recalling approximately 2,312 units of Product Code 0847, the MEGA SOFT Universal Plus Patient Return Electrode, a reusable electrode used in surgical procedures.
The recall was initiated due to reports of patient burn injuries, including third-degree burns that required medical intervention. Affected patients experienced hospitalization, scarring, and the need for additional surgeries in both pediatric and adult populations.
The affected product has been distributed worldwide, including throughout the United States and Puerto Rico. As a result of the recall, the product is restricted to use in patients age 12 years and older.
The recalled product
- Product
- Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 2,312
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 10614559104842 All units in 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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