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Megadyne Medical Products, Inc. FDA Recalls
17 recalls on file across devices, 16 of them Class I and 17 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
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| Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Class IJun 17, 2024To limit the use of the Mega Soft Pads to patients aged 12 o |
| Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Class IJun 17, 2024To limit the use of the Mega Soft Pads to patients aged 12 o |
| Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual ReusablClass IJun 17, 2024To limit the use of the Mega Soft Pads to patients aged 12 o |
| MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50Class IMay 8, 2024Reports of patient burns. |
| Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega SClass IDec 8, 2023Affected product codes are now limited to use in patients ag |
| Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return ElectrodeClass IDec 8, 2023Affected product codes are now limited to use in patients ag |
| Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, MClass IDec 8, 2023Affected product codes are now limited to use in patients ag |
| Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega SClass IDec 8, 2023Affected product codes are now limited to use in patients ag |
| MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Class IIJun 15, 2023An issue with the Suction Coagulator product family may lead |
| MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |
| MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgeryClass IJun 1, 2023Firm has received reports of patient burns in surgical proce |