Megadyne Mega Soft Universal Patient Return Electrode Recalled for Burn Risk
Megadyne Medical Products is recalling 21,100 MEGA SOFT electrosurgery patient return electrodes distributed nationwide due to reports of patient burns during surgical procedures.
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 a Class I FDA medical device recall with reported patient burns. FDA Class I recalls represent serious hazards and mandate a minimum score of 4. The reported patient injuries confirm significant harm risk.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode (Model No. 0846, UDI-DI: 10614559104248), a device used during electrosurgery. Approximately 21,100 units were distributed nationwide.
The firm has received reports of patient burns occurring during surgical procedures where this device was used.
Healthcare providers and facilities using this device should contact Megadyne Medical Products for further instructions regarding this recall.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- Affected units
- 21,100
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 (3)
- Model No. 0846
- UDI-DI: 10614559104248
- All Units.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 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 8 products in this recall →Related recalls
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- Severe
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