FDA notifies veterinarians of animal burn risk linked to human medical devices

Following a recall of grounding pads produced by Megadyne, a machinery industry company, the FDA is notifying veterinarians about a potential burn risk linked to the use of these devices in veterinary patients, according to a “Dear Veterinarian” letter written by the federal agency. The FDA’s Center for Veterinary Medicine (CVM) received reports of burn injuries in animals related to the use of these human medical devices in veterinary settings, stated the letter.¹ The recall involves updating the usage instructions of these devices, but does not involve removing the products from where they are used or sold.

The recall, which includes the Megadyne Mega Soft, Mega Soft Dual, and Mega 2000 Patient Return Electrodes, are human medical devices that are often used in veterinary practice. The recall was issued by the CVM on January 14, 2025, and comes after the agency was made aware of human patient burn injuries, particularly among children under 12 years of age.

Megadyne Mega Soft Patient Return Electrode. (Photos courtesy of FDA)

Megadyne Mega 2000 Patient Return Electrode

Speaking of the affected animal patients, the FDA wrote, “The animal adverse event reports received by the FDA included dogs of varying weights and ages. Human medical devices are often used for animal patients in veterinary practice. FDA has regulatory oversight over devices intended for animal use and can take appropriate regulatory action if an animal device is misbranded or adulterated. However, FDA does not currently have premarket authority over devices intended solely for animals.”¹

Megadyne is addressing the issues with the affected grounding pads following the reports of patient burn injuries, according to the FDA. The company is directing users to not use the Mega Soft, Mega Soft Dual, and Mega 2000 Patient Return Electrodes on children under 12 years. It is also instructing users to ensure they follow the proper cleaning, placement, and setup steps to help prevent burns in patients associated with the devices.

The Megadyne grounding pads are soft pads used in electrosurgery—a procedure where an electric current is used to heat or cut tissue, or to stop bleeding. The current is generated by an electrosurgical generator and delivered to the tissue via a small, pen-like attachment. A return electrode pad is placed on the patient’s skin to direct the current back to the generator in order to lower the risk of excessive heating.¹

In its letter, the FDA advised veterinarians and animal owners to “report adverse experiences and product defects” linked to animal devices. These can include²:

• Adverse effects in animals including but not limited to
  • Vomiting
  • Diarrhea
  • Colic
  • Seizures
• Adverse effects (such as needle stick injuries, rashes, or headache or nausea secondary to product contact) in humans that had exposure to drugs and devise used in animals
• Defects in products, with examples including broken product seals, leaking bottles, and more
• Medication errors, like administering the incorrect drug or dose, giving a drug too often, and more
• A product’s lack of effectiveness, such as a product that is not working or stops working, or one that is no longer working as well as it once did

Reports the agency receives are used to monitor the safety of products after they become available to the market.² More information on reporting information about animal drugs and devices is available on the FDA’s “How to Report Animal Drug and Device Side Effects and Product Problems” website.^1,2

References

1. Dear Veterinarian Letter advising veterinarians of burn risk associated with the use of Megadyne grounding pads in veterinary patients. News release. US Food and Drug Administration. January 14, 2025. Accessed February 6, 2025. https://www.fda.gov/animal-veterinary/product-safety-information/dear-veterinarian-letter-advising-veterinarians-burn-risk-associated-use-megadyne-grounding-pads
2. How to Report Animal Drug and Device Side Effects and Product Problems. US Food and Drug Administration. Accessed February 6, 2025. https://www.fda.gov/animal-veterinary/report-problem/how-report-animal-drug-and-device-side-effects-and-product-problems