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Official recall record

Mega Soft Universal Patient Return Electrode

Health Canada — Medical Devices · 2024-05-15 · CanadaType I
Issuing authority
Health Canada — Medical Devices
Published
2024-05-15
Country of alert
Canada
Alert level
Type I
Alert type
recall

What the authority reported

Megadyne has received reports of patient burn injuries in procedures where the Mega Soft Patient Return Electrodes were used. A root cause investigation on the reports included testing which showed a combination of factors when present together may result in potential for thermal injuries. The combination of these conditions may be more likely when the pad is used with infants and small children. Recall Start Date: May 8, 2024

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: Health Canada — Medical Devices — official record →
Record last checked against the registry on 2026-05-31.

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