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FDA Issues Safety Alert for Radiofrequency Microneedling
The FDA reports serious injuries including burns and nerve damage from RF microneedling, urging treatments only by licensed, experienced providers.
- On Nov. 3, 2025 the U.S. Food and Drug Administration issued a safety alert warning consumers, patients and healthcare providers about serious complications from RF microneedling procedures used on the face and neck.
- The RF microneedling technique uses an array of tiny needles to deliver radiofrequency energy and heat into the skin, which promotes collagen growth but the FDA has received reports of serious injuries linked to the procedure.
- Patients and caregivers are urged to consider reported complications before deciding on the procedure, as the FDA has received reports of serious injuries, including burns and nerve damage.
- Both patients and providers should report complications to the FDA via MedWatch, and the agency is working with manufacturers while recommending care only from licensed providers with specific training.
- Many RF microneedling devices are cleared as Class II medical devices, but the FDA stresses the procedure is medical, used for face and neck uses, and should never occur at home.
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Q&A: FDA warns of radiofrequency microneedling risks; here’s what to know
The FDA recently issued a safety communication warning patients and health care professionals of serious complications reported after using some radiofrequency microneedling devices, according to a press release. Radiofrequency (RF) microneedling devices that are FDA-cleared for the use of dermatologic or aesthetic purposes have reportedly caused “serious complications,”
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FDA Issues Safety Alert for Radiofrequency Microneedling
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Coverage Details
Total News Sources25
Leaning Left4Leaning Right4Center8Last UpdatedBias Distribution50% Center
Bias Distribution
- 50% of the sources are Center
50% Center
L 25%
C 50%
R 25%
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