The FDA’s MAUDE adverse event database holds 60 reports filed under QAI, the product code for microneedling devices, in data last updated by openFDA on September 29, 2026. Searched by brand, Dr. Pen has 2 reports, Dermapen 2, SkinPen 13, and Derminator 3, which are filed under a different product code. None of these numbers…
Since January 6, 2026, two Dr. Pen handpieces, the A20 and A9, have held an active Health Canada medical device license (number 114618). That is a reversal for part of a brand that Health Canada told Canadians on December 16, 2021 not to buy or use, because “Dr. pen microneedling pens and cartridges are not…
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…
The FDA cleared eight microneedling devices under product code QAI between March 6, 2025 and May 13, 2026, the most recent decision on record. Every one is a prescription device. None was cleared for over-the-counter or home use, and four of the eight are cleared for one indication only: improving the appearance of facial acne…