MEGADYNE MEGA 2000 Patient Return Electrode Recalled Due to Patient Burns
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode due to reports of patient burns during electrosurgical procedures. All units distributed nationwide are affected.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: This recall is classified as FDA Class I, which is explicitly listed as a Critical severity criterion in the rubric. The source documents reports of patient burns during use, confirming that actual harm has been reported.
Plain-English summary
The FDA is recalling 21,100 units of the MEGADYNE MEGA 2000 Patient Return Electrode, a device used during electrosurgical procedures. The recall was initiated after the manufacturer received reports of patient burns occurring during surgical procedures where this device was used.
The affected device is Model No. 0800, manufactured by Megadyne Medical Products, Inc., with UDI-DI 10614559100936. These units were distributed nationwide throughout the United States.
Healthcare facilities that received this device should review their inventory for affected units and contact the manufacturer for guidance. Patients who underwent electrosurgical procedures using this device should consult their healthcare provider if they experienced burns or have concerns about complications.
The recalled product
- Product
- MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
- Manufacturer
- Megadyne Medical Products, Inc.
- Hazard
- burn-injury
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. 0800
- UDI-DI: 10614559100936
- All Units.
Distribution
Distributed nationwide across the United States.
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