# FDA recall Z-1920-2024

> **Megadyne Medical Products, Inc.** · Class I · device recall initiated 2024-05-08.

## Product

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.

## Reason for recall

Reports of patient burns.

## Distribution

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.

## Key facts

- **Recall number:** Z-1920-2024
- **Recalling firm:** Megadyne Medical Products, Inc.
- **Classification:** Class I
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-05-08
- **Report date:** 2024-06-12

- **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-1920-2024

## Citation

> AI Analytics. FDA recall Z-1920-2024. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/Z-1920-2024. Source: US FDA. Licensed CC0.

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