Patient Return Electrode Recalled Due to Burn Reports During Surgery
Megadyne Medical Products is recalling MEGA SOFT Universal Patient Return Electrodes after reports of patient burns during electrosurgery procedures. The FDA classified this as a Class I recall.
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 have a minimum severity score of 4. The firm reported patient burns during surgical use, which are significant injury reports that support a Severe classification.
Plain-English summary
Megadyne Medical Products, Inc. is recalling the MEGA SOFT Universal Patient Return Electrode (Model No. 0845, UDI-DI: 10614559103906), which is used as a grounding component during electrosurgery procedures.
The FDA has classified this recall as Class I because the company has received reports of patient burns occurring during surgical procedures involving use of this device.
Approximately 21,100 units were distributed to healthcare facilities across the United States. Patients who have undergone surgery using this electrode should contact their healthcare provider if they experienced unexpected burns or skin injuries. Healthcare providers should immediately remove the affected device from clinical use.
The recalled product
- Product
- MEGADYNE MEGA SOFT Universal 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. 0845
- UDI-DI: 10614559103906
- 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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