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Megadyne Medical Products Recalls
20 recalls on record · September 4, 2013 to July 10, 2024 · Medical Devices
Recalls by year
13
14
18
23
24
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
July 10, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusabl
Hazard: 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.
July 10, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient
Hazard: 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.
July 10, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode
Hazard: 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.
June 12, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50
Hazard: Reports of patient burns.
January 3, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M
Hazard: 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.
January 3, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S
Hazard: 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.
January 3, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega S
Hazard: 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.
January 3, 2024Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
Hazard: 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.
August 9, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product
Hazard: 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).
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
July 5, 2023Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Hazard: Firm has received reports of patient burns in surgical procedures where device was used.
August 22, 2018Medical DevicesFDA
Megadyne Medical Products, Inc. recalls MegaPower Electrosurgical Generator, Product code 1000, GTIN 10614559103715
Hazard: If two devices are plugged into the same channel/port in the generator, both devices activate. If one device is left laying on the patient, the result could be burning of the patient.
March 19, 2014Medical DevicesFDA
Megadyne Medical Products, Inc. recalls Hand Control 12FR Suction Coagulator with 10 ft cord and holster, Sterile, Disposable, Model Number 0043-25, packaged Ty
Hazard: Megadyne Medical Products, Inc. is voluntarily recalling Hand Control 12Fr Suction Coagulator with 10ft cord and 132405 Holster, Sterile, Disposable, Lot 132405 due to the potential for a small number of these suction coagulators to self-activate immediately on connection to the electrosurgical generator and to remain activated until it is disconnected.
September 4, 2013Medical DevicesFDA
Megadyne Medical Products, Inc. recalls E-Z Clean¿ Disposable Laparoscopic Electrode Model Number 0100L and 0100LS. Expiration dates of 05/2018 to 07/2018. Ste
Hazard: Megadyne Medical Products is recalling certain lots of E-Z Clean, L-Wire laproscopic Electrode Standard Stem and Split Stem due to potential breach of insulation.