Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-5…

Recall date

May 8, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1920-2024

FDA classification

Class I

Brand / firm

Megadyne Medical Products, Inc.

Sold / distributed

Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thail…

Why it was recalled

Reports of patient burns.

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 Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.