MEGADYNE MEGA SOFT Return Electrode Recalled for Burns During Surgical Procedures
Megadyne Medical Products is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode due to reported patient burns that occurred during electrosurgical 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 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 documented patient injury reports (burns) occurring during use. FDA Class I classification indicates a reasonable probability of serious adverse health consequences, and the reported patient burns confirm actual harm has occurred.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode (Model No. 0848). The device is used as a return electrode during electrosurgical procedures to complete the electrical circuit during surgery.
The company has received reports of patient burns occurring during surgical procedures where the device was used. This Class I recall indicates a reasonable probability that the device use could cause serious adverse health consequences.
The recalled devices were distributed nationwide across the United States. Affected units have UDI-DI 10614559104859. Approximately 21,100 units are subject to this recall.
Healthcare facilities and surgical centers currently using this device should immediately cease use and contact Megadyne Medical Products for replacement units or further guidance. Patients who have undergone surgical procedures with this device and experienced burns or other adverse effects should contact their healthcare provider.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal Plus 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. 0848
- UDI-DI: 10614559104859
- 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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