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This page describes products and general use; it is not medical advice.
An electrosurgical grounding pad is the lay and search term for what FDA calls a patient return electrode: a pad that touches the patient’s skin during electrosurgery and carries current from the patient’s tissue back to the electrosurgical generator. This page is for clinic staff, buyers and students who need to identify the product and understand what FDA has published about burn risk.
What an electrosurgical grounding pad is
FDA’s recall notices describe soft reusable pads used in electrosurgery. The pad contacts the skin and carries current from the patient’s tissue back to the generator, “to reduce the risk of excessive heating.” In FDA’s wording the device is a patient return electrode or return electrode pad; “grounding pad” and “electrosurgery grounding pad” are informal names for the same product. Users: operating-room and procedure staff who set up the generator, staff who clean reusable pads, and facilities that buy them.
The generator itself is covered in What Is an Electrosurgical Unit?. Under 21 CFR 878.4400 the electrosurgical cutting and coagulation device is “intended to remove tissue and control bleeding by use of high-frequency electrical current” and is Class II; that regulation text does not itself mention return electrodes.
Why burns happen and what FDA reported
Because the pad is the path for returning current, a pad that heats the skin can burn it. FDA has published two U.S. recall notices for one manufacturer’s pads (Megadyne) in which burns were reported:
- MEGA 2000 and MEGA SOFT reusable pads (2023). Eight models (codes 0800-0848), 21,200 devices in the U.S., distributed 2021-03-11 to 2023-05-09; the firm initiated the recall on 2023-06-01. FDA classed it Class I, “the most serious type of recall.” Reported: 63 injuries, no deaths. At the time of the notice the root cause was under evaluation. It was a voluntary correction, not a removal.
- MEGA SOFT Pediatric pad, code 0840 (2024). A removal letter dated 2024-05-08. Reported: 4 injuries including third-degree burns, no deaths.
Reusable and pediatric pads in the FDA notices
| Pad in the notice | Intended patients / form | FDA action |
|---|---|---|
| MEGA 2000 / MEGA SOFT (codes 0800-0848) | Reusable soft pads for electrosurgery | Class I voluntary correction, initiated 2023-06-01; facilities told to confirm staff follow the instructions for use (IFU) |
| MEGA SOFT Pediatric (code 0840) | Pediatric pad for patients weighing 0.8 to 50 lb | Removal; users told to stop using, quarantine and return the pads |
Sources: the two FDA recall notices listed below.
Children under 12
In a letter to veterinarians (current as of 2025-01-14) FDA stated that burn reports came especially in “children under 12 years of age” and that the manufacturer is instructing users not to use the affected pads during procedures with patients under 12 years old. The same letter says affected devices are reusable and also refers to “proper cleaning, placement, and setup steps” for the pads. For animal-only devices FDA noted it lacks premarket authority.
What facilities are told to do
FDA’s recommended actions in the 2023 notice for facilities holding the affected reusable pads were:
- Share the notice with cleaning, operating-room setup and operator staff.
- Confirm staff follow the manufacturer’s IFU.
- Post cleaning and placement visual aids.
- Return the manufacturer’s Business Reply Form within 3 business days.
- Report problems to FDA MedWatch.
For the pediatric pad the action was different: stop using, quarantine and return the pads. The pediatric notice gives no placement guidance, so placement questions go to the pad’s own IFU.
Common mistakes
- Treating a recall notice as relevant only to the operating room, when FDA directs it to cleaning and setup staff too.
- Continuing to use a pad after a removal notice instead of quarantining it as directed.
- Searching only for “grounding pad” and missing notices filed under “patient return electrode.”
FAQ
Is a grounding pad the same as a return electrode?
Yes in everyday use. FDA’s pages call the product a patient return electrode (or return electrode pad); “grounding pad” is the informal term.
Does the pad ground the patient?
FDA’s description is that the pad carries current from the patient’s tissue back to the generator. That is why FDA uses the term return electrode.
Where does an electrosurgery grounding pad fit in a clinic’s supplies?
Offices that perform electrosurgery list pads among consumables where the unit requires one; see the dermatology office supply checklist. A related electrosurgery topic is smoke evacuation.
Sources
- FDA, Megadyne recalls MEGA 2000 and MEGA SOFT reusable patient return electrodes (risk of serious burn), checked 2026-11-01: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/megadyne-recalls-mega-2000-and-mega-soft-reusable-patient-return-electrodes-risk-serious-burn
- FDA, Megadyne removes MEGA SOFT Pediatric patient return electrodes, checked 2026-11-01: https://www.fda.gov/medical-devices/medical-device-recalls-and-early-alerts/electrode-pad-recall-megadyne-removes-megadyne-mega-soft-pediatric-patient-return-electrodes-risk
- FDA, Dear Veterinarian letter on burn risk with Megadyne grounding pads (current as of 2025-01-14), checked 2026-11-01: https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-advising-veterinarians-burn-risk-associated-use-megadyne-grounding-pads
- 21 CFR 878.4400, electrosurgical cutting and coagulation device, eCFR, checked 2026-11-01: https://www.ecfr.gov/current/title-21/part-878/section-878.4400
