• Posted November 3, 2025

FDA Issues Safety Alert for Radiofrequency Microneedling

The U.S. Food and Drug Administration (FDA) is warning consumers, patients and healthcare providers about the potential risk for serious complications from radiofrequency (RF) microneedling procedures.

RF microneedling devices are commonly used to improve skin appearance of the face and neck — often referred to as “resurfacing,” “tightening” or “rejuvenation” to treat issues like wrinkles.

The technology works by using an array of tiny needles (microneedles) to deliver RF energy and heat into the skin. This heat is intended to cause controlled changes in the tissue, promoting new collagen growth, according to the FDA.

However, the FDA has received numerous reports of serious and potentially permanent injuries related to the microneedling procedure.

The adverse events reported to the agency include:

• Severe burns

• Permanent scarring

• Fat loss (diminishing facial volume)

• Physical disfigurement

• Nerve damage

These reported injuries have occasionally required follow-up surgical repair or medical intervention to treat the harm.

Many RF microneedling devices are cleared by the FDA as Class II medical devices, but the agency stresses that an RF microneedling procedure is a medical procedure, not a simple cosmetic treatment.

The agency notes that these devices should never be used at home, and only with an experienced and licensed provider.

While the FDA continues its evaluation of these devices and works with manufacturers to identify ways to reduce these risks, it has provided key recommendations for those considering or performing the treatment.

Patients and caregivers are urged to be fully aware of these reported serious complications before deciding to have the procedure.

They should:

• Discuss the benefits and risks of RF microneedling and all alternative skin procedures with a licensed healthcare provider.

• Get care only from a licensed provider with specific training and experience in using RF microneedling devices.

• Seek medical care immediately if any problems or unusual symptoms are experienced after a procedure.

The FDA also emphasized that healthcare providers must be aware of these reported complications and should review the risks with its patients.

Both patients and providers are encouraged to report any problems or complications experienced with RF microneedling devices to the FDA through their MedWatch Voluntary Reporting Form.

More information

For more information on uses and safety, the FDA provides a search tool for medical devices including FDA-cleared RF microneedling devices.

SOURCE: U.S. Food and Drug Administration, Oct. 15, 2025