MEGADYNE MEGA SOFT Reusable Patient Return Electrode Recalled for Burn Risk
Megadyne Medical recalls MEGA SOFT reusable patient return electrodes (Model 0830) due to identified burn risk. Use is restricted to patients aged 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: FDA Class I recalls carry a minimum severity threshold of 4. Although no reported injuries or deaths are documented, the identified burn risk and mandatory age-based mitigation confirm a serious patient safety hazard warranting this classification.
Plain-English summary
The MEGADYNE MEGA SOFT Reusable Patient Return Electrode, Model 0830, has been recalled by the FDA due to an identified risk of patient burns. This device is used as a patient return electrode in electrosurgical procedures. Approximately 2,584 units were distributed nationwide and internationally.
The burn risk was identified during clinical use. To mitigate this hazard, the manufacturer recommends restricting use of the device to patients aged 12 years or older. The product code 0830 has been discontinued from future production.
Consumers and healthcare providers should stop using this device in patients younger than 12 years. Healthcare facilities should review their inventory and implement the age-based use restrictions. For more information or to report adverse events, contact Megadyne Medical Products, Inc. or the FDA.
The recalled product
- Product
- Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For…
- Manufacturer
- Megadyne Medical Products, Inc.
- Category
- Medical Device — Electrosurgical
- Hazard
- Affected units
- 2,584
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 (2)
- Product Code: 0830
- UDI-DI: 10614559101797
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 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 3 products in this recall →Related recalls
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