Megadyne Medical Products, Inc.: Device Recall

Recall #Z-2249-2024 · 06/17/2024

Class I: Dangerous

Recall Details

Recall Number: Z-2249-2024
Classification: Class I
Product Type: Device
Recalling Firm: Megadyne Medical Products, Inc.
Status: Ongoing
Date Initiated: 06/17/2024
Location: Blue Ash, OH, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2584 units

Reason for Recall

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.

Product Description

Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

Distribution Pattern

Domestic: Nationwide distribution International: AUSTRALIA, AUSTRIA, BAHRAIN, BELGIUM, CANADA, CHINA, GERMANY, GREECE, INDIA, ITALY, NETHERLANDS, NORWAY, JAPAN, SAUDI ARABIA, SINGAPORE, SOUTH KOREA, SPAIN, THAILAND, TURKEY, UNITED KINGDOM, UNITED STATES,

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 05/08/2024

Reports of patient burns.

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.