# FDA recall Z-2248-2024

> **Megadyne Medical Products, Inc.** · Class I · device recall initiated 2024-06-17.

## Product

Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode  Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode  Model/Catalog Number: 0800  Software Version: N/A  Product Description: Reusable Patient Return Electrode, Mega 2000, Adult, For Patients Weighing over 25lbs. (11.4Kg), 91cm Long x 51cm Wide  Component: No

## 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.

## Distribution

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,

## Key facts

- **Recall number:** Z-2248-2024
- **Recalling firm:** Megadyne Medical Products, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-06-17
- **Report date:** 2024-07-10

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Blue Ash, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2248-2024

## Citation

> AI Analytics. FDA recall Z-2248-2024. Retrieved 2026-06-23 from https://api.ai-analytics.org/recall/Z-2248-2024. Source: US FDA. Licensed CC0.

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