Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
- Recall date
- June 1, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-1998-2023
- FDA classification
- Class I
- Brand / firm
- Megadyne Medical Products, Inc.
- Sold / distributed
- Distributed US Nationwide.
Why it was recalled
Firm has received reports of patient burns in surgical procedures where device was used.
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
What was recalled
MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
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