Drug & Device Safety Atlas

FDA recall record · openFDA

Megadyne Medical Products, Inc.

17 FDA recalls on record (2023–2024) — 17 device. 17 still ongoing.

16
Class I (most serious)
1
Class II
0
Class III
17
ongoing

How to read this. A recall count is not a quality verdict — large manufacturers recall more simply by volume, and a voluntary recall is the safety system working as intended. The signal to weight is the Class I count (the FDA's most-serious tier — reasonable probability of serious harm or death) and whether recalls are still ongoing. Most recalls are Class II/III. "Ongoing" reflects openFDA's last-published status — device recalls often stay marked ongoing long after they're resolved in practice; confirm current status at the FDA.

Most common reasons

Firm has received reports of patient burns in surgical procedures where device was used. 8
Affected product codes are now limited to use in patients age 12 years or older. Megadyne has received reports of patien 4
To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns iden 3
An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead 1
Reports of patient burns. 1

Recalls

Brand Name: MEGADYNE" MEGA SOFT" Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Reusable Patient Class I 2024-06-17 Brand Name: MEGADYNE" MEGA 2000" Patient Return Electrode Product Name: MEGADYNE" MEGA 2000" Patient Return Electrode Class I 2024-06-17 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50 Class I 2024-05-08 Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusabl Class I 2024-06-17 MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode. used during electrosurgery Class I 2023-06-01 MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode. used during electrosurgery Class I 2023-06-01 MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. used during electrosurgery Class I 2023-06-01 MEGADYNE MEGA 2000 Patient Return Electrode. used during electrosurgery Class I 2023-06-01 Product Code 0848, MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode, Reusable Patient Return Electrode, M Class I 2023-12-08 MEGADYNE MEGA SOFT Reusable Patient Return Electrode. used during electrosurgery Class I 2023-06-01 Product Code 0847, MEGADYNE MEGA SOFT Universal Plus Patient Return Electrode, Reusable Patient Return Electrode, Mega S Class I 2023-12-08 MEGADYNE MEGA SOFT Universal Plus Dual Patient Return Electrode. used during electrosurgery Class I 2023-06-01 Product Code 0846, MEGADYNE MEGA SOFT Universal Dual Patient Return Electrode, Reusable Patient Return Electrode, Mega S Class I 2023-12-08 Product Code 0845, MEGADYNE MEGA SOFT Universal Patient Return Electrode, Reusable Patient Return Electrode Class I 2023-12-08 MEGADYNE MEGA SOFT Dual Reusable Patient Return Electrode. used during electrosurgery Class I 2023-06-01 MEGADYNE MEGA SOFT Universal Patient Return Electrode. used during electrosurgery Class I 2023-06-01 MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Class II 2023-06-15

RECORDED — these are the FDA's published recall enforcement records (openFDA). Recalls are listed under the exact firm name as filed; a large manufacturer may also file under name variants, so this may not be the company's complete cross-variant record — confirm at the FDA recall database. This page informs and routes; it is not medical advice or a verdict on the company.

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