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# FDA Warns on RF Microneedling Devices
- URL: https://www.fdaweb.com/fda-warns-on-rf-microneedling-devices/
- Published: 2025-10-15T12:00:00.000Z
- Updated: 2026-09-14T15:24:13.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160046

FDA has issued a new [safety communication](https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication?utm%5Fmedium=email&utm%5Fsource=govdelivery) warning about reports of serious complications associated with certain uses of radiofrequency (RF) microneedling devices, commonly used in aesthetic skin treatments. The devices deliver radiofrequency energy through tiny needles to heat tissue under the skin, a process marketed for skin tightening, wrinkle reduction, and rejuvenation. However, the agency says it has received reports of severe adverse events, including burns, scarring, fat loss, disfigurement, nerve damage, and in some cases, the need for surgical repair or other medical interventions.

While FDA’s evaluation is ongoing, it is urging patients and providers to report any complications from RF microneedling procedures. It is also working with manufacturers to investigate the cause and to identify potential mitigation strategies.