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Mega soft electrodes
Official notice
20 Dec 2023
Last checked
20 Dec 2023
An official Health Canada notice concerns Mega soft electrodes. Megadyne has received reports of patient burns identified after surgical procedures in which mega soft pads were used. Megadyne is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age. We have conducted a thorough investigation, and have not identified any design or manufacturing defects, nor have we determined definitive root cause for the reports. Recall Start Date: December 12, 2023 Published 2023-12-20.
What to do now
Contact the manufacturer if you require additional information.
Recall number
74766
Official notice
2023-12-20
The hazard
The hazard
Megadyne has received reports of patient burns identified after surgical procedures in which mega soft pads were used. Megadyne is taking this corrective action to mitigate the potential risk to health in the population of children under 12 years of age. We have conducted a thorough investigation, and have not identified any design or manufacturing defects, nor have we determined definitive root cause for the reports. Recall Start Date: December 12, 2023
How to check if you're affected
How to check if you're affected
Compare the product name and identifiers below with the item you own. Follow the official notice if they match.
Recall Numbers
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Affected products
Product 1
Product 2
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Risk / hazard
Where it was sold
Where it was sold
The source does not list specific retailers. See the official notice for where affected products were sold.
Location 1
Affected area 1
Company & contacts
Company & contacts
Brand: Megadyne Medical, Mega Soft Electrodes.
Source & status
Source & status
Source
Tier
Category
Classification
App estimate
Recall details
Recall details
Recall number
Classification
Source tier
Documents, notices & source
See the official notice and source documents for full details.
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