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.
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 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
- 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. 0800
- UDI-DI: 10614559100936
- 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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