Megadyne Medical Products, Inc.: Device Recall

Recall #Z-1920-2024 · 05/08/2024

Class I: Dangerous

Recall Details

Recall Number: Z-1920-2024
Classification: Class I
Product Type: Device
Recalling Firm: Megadyne Medical Products, Inc.
Status: Ongoing
Date Initiated: 05/08/2024
Location: Blue Ash, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 1270

Reason for Recall

Reports of patient burns.

Product Description

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.

Distribution Pattern

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, Thailand, United Arab Emirates, and United Kingdom.

Other Recalls by Megadyne Medical Products, Inc.

Class I: Dangerous 06/17/2024

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Class I: Dangerous 06/17/2024

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.
Class I: Dangerous 06/17/2024

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

View all recalls by Megadyne Medical Products, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.