Megadyne Medical Products, Inc.
17 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Megadyne Medical Products, Inc. and translate it into plain English — free weekly digest, optional same-day alerts.
- 2024-07-10FDA-DeviceClass IBrand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
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.
- 2024-07-10FDA-DeviceClass IBrand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Model/Catalog Number: 0830 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Single Cord, Adult, For Patients Weighing over 25lbs (11.4Kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No
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.
- 2024-07-10FDA-DeviceClass IBrand 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
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.
- 2024-06-12FDA-DeviceClass IMEGADYNE 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.
Reports of patient burns.
- 2024-01-03FDA-DeviceClass IProduct Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Plus
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.
- 2024-01-03FDA-DeviceClass IProduct Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Plus
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.
- 2024-01-03FDA-DeviceClass IProduct Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega Soft Universal Dual Cord
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.
- 2024-01-03FDA-DeviceClass IProduct Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode
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.
- 2023-08-09FDA-DeviceClass IIMEGADYNE 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)
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).
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
- 2023-07-05FDA-DeviceClass IMEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery
Firm has received reports of patient burns in surgical procedures where device was used.
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