Megadyne Medical Products, Inc. Recalls

All product recalls associated with Megadyne Medical Products, Inc..

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Recall Summary

Total Recalls

14

Past Year

0

Class I (Serious)

0

Most Recent

Jun 2024

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–14 of 14 recalls

Megadyne Medical Products, Inc.: Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return ...

Fire/Burn Risk

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.

Moderate

FDAJun 17, 2024Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode...

Fire/Burn Risk

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.

Moderate

FDAJun 17, 2024Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Re...

Fire/Burn Risk

Reports of patient burns.

Moderate

FDAMay 8, 2024Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: Product Code 0845, MEGADYNE MEGA SOFT Universal Patient R...

Fire/Burn Risk

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Moderate

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Pati...

Fire/Burn Risk

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Moderate

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual...

Fire/Burn Risk

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Moderate

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Pati...

Fire/Burn Risk

Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patient burn injuries up to and including third-degree burns requiring intervention which may lead to prolonged hospital stay, scarring, and additional surgeries in both pediatric and adult patients.

Moderate

FDADec 8, 2023Nationwide• Megadyne Medical Products, Inc.

Megadyne Medical Products, Inc.: MEGADYNE Suction Coagulators, Product Code 004125 (Suctio...

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).

Moderate

FDAJun 15, 2023Nationwide• Megadyne Medical Products, Inc.