FDA Safety Communication on RF Microneedling

On October 15, 2025, the FDA issued a safety communication saying it was aware of reports of “serious complications” with radiofrequency (RF) microneedling, and that “RF microneedling is a medical procedure, not a cosmetic treatment, and these devices should not be used at home.” It is a warning, not a recall: the communication names no device or manufacturer and does not ask anyone to stop selling a product.

The page still reads “Content current as of: 10/15/2025” when checked on October 6, 2026.

The complications the FDA listed

The communication covers RF microneedling used “to treat wrinkles or to achieve skin effects, sometimes referred to as resurfacing, ‘tightening’ or ‘rejuvenation'”. For those uses, the FDA said it was “aware of reports of serious complications (adverse events) including burns, scarring, fat loss, disfigurement, and nerve damage, and the need for surgical repair or medical intervention to treat injuries.”

It does not say how many reports it had received, or over what period.

What the FDA told patients

The recommendations for patients and caregivers, in full:

“Be aware of reports of serious complications such as burns, scarring, fat loss, disfigurement, and nerve damage, with use of RF microneedling devices for dermatologic and aesthetic skin procedures.”
“Discuss the benefits and risks of all available dermatologic and aesthetic skin procedures with your health care provider.”
“If you are considering a skin procedure using RF microneedling, seek care from a licensed health care provider with training and experience on the use of RF microneedling devices, and ask your provider which devices they plan to use.”
“RF microneedling is a medical procedure, not a cosmetic treatment, and these devices should not be used at home.”
“If you experience any problems or are concerned after a skin procedure using RF microneedling, seek care from a licensed health care provider.”
Report any problems or complications to the FDA.

Health care providers were asked to discuss the same points with patients and to report complications.

What the FDA said it is doing

“The FDA is working with manufacturers of these devices to evaluate the issue and identify mitigation strategies as appropriate,” the communication says, and the agency “will continue to monitor reports of adverse events and keep the public informed if significant new information becomes available.” It describes its evaluation as “ongoing”.

The communication also describes how these devices reach the market: “RF microneedling devices are Class II medical devices cleared by the FDA through the 510(k) process.” The FDA has continued to clear them since. The site’s FDA records include two RF systems cleared under product code GEI after the communication: LUTRONIC GENIUS (K253484, Cynosure Lutronic Technology Corporation, June 29, 2026) and Potenza Prime (K254185, Jeisys Medical Incorporated, September 11, 2026).

What has been published since

A cross-sectional study in Dermatologic Surgery (2026), which cites the October 15 communication in its background, searched the FDA’s MAUDE adverse event database for RF microneedling reports from 2020 to 2025. Its abstract reports 86 medical device reports containing 145 adverse events, with fat loss, scarring and postinflammatory erythema the most often reported.

MAUDE reports are unverified and cannot show how often a problem happens, so that count is not a complication rate. Our MAUDE roundup explains the limits.

What it means for buyers

RF microneedling is not the same thing as a microneedling pen. It adds heat delivered through the needles. The communication is about RF devices only, and it does not mention plain mechanical pens, rollers or stamps.

A home RF device is outside what the FDA advises. The agency’s wording, “these devices should not be used at home”, applies to RF microneedling devices as a group. It does not single out any product.

If you book a treatment, the FDA’s own suggestion is to ask the provider which device they plan to use. A device’s clearance and its indication can be looked up by name in the FDA’s 510(k) database, and our RF microneedling page lists the cleared systems and what each was cleared for.

No company response was sought: this post reports regulator records.

Last updated: October 6, 2026. FDA page checked October 6, 2026.

Sources

FDA, “Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication”, issued October 15, 2025, content current as of 10/15/2025 (checked 2026-10-06): https://www.fda.gov/medical-devices/safety-communications/potential-risks-certain-uses-radiofrequency-rf-microneedling-fda-safety-communication
PMID 42430734: Camacho-Hubbard I et al. Safety Considerations and Complications With Radiofrequency Microneedling: A Cross-Sectional Analysis of the US FDA MAUDE Database. Dermatol Surg, 2026. https://pubmed.ncbi.nlm.nih.gov/42430734/
K253484, LUTRONIC GENIUS, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K253484.pdf
K254185, Potenza Prime, 510(k) summary: https://www.accessdata.fda.gov/cdrh_docs/pdf25/K254185.pdf
FDA, About the MAUDE database, “Limitations of Medical Device Reports”: https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/manufacturer-and-user-facility-device-experience-database-maude