# FDA recall Z-2257-2023

> **Megadyne Medical Products, Inc.** · Class II · device recall initiated 2023-06-15.

## Product

MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)

## Reason for recall

An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU).

## Distribution

Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, UNITED ARAB EMIRATES, UNITED KINGDOM, VIETNAM

## Key facts

- **Recall number:** Z-2257-2023
- **Recalling firm:** Megadyne Medical Products, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2023-06-15
- **Report date:** 2023-08-09

- **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-2257-2023

## Citation

> AI Analytics. FDA recall Z-2257-2023. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/Z-2257-2023. Source: US FDA. Licensed CC0.

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