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Recap of the FDA Microneedling Situation
In 2024, Amazon pulled nearly all Dr. Pen devices and cartridges from their platform, websites stopped selling them, and a lot of people thought the FDA had officially banned them. Here I’ll give you an update on that.
The FDA also recently released a statement – a warning of potential risks and dangers that are specific to RF microneedling. I’ll share that with you – and I’ll also share some recommendations on buying high-quality microneedling supplies.
What’s Going On With the FDA and Microneedling
The FDA has been reviewing at-home microneedling devices since at least 2023. I have a full write-up sharing the details behind that here: Is At Home Microneedling Being Banned?
If you didn’t know this, Dr. Pen is a brand of microneedling devices sold by the official manufacturer in China, named Guangzhou Ekai Electronic Technology Co., (Ekai for short). So there are many companies that work as licensed resellers for Dr. Pen devices. There are also many others selling look-alike products that aren’t official resellers, which makes it hard to know exactly who made those devices.
When Amazon pulled devices off of their platform, a while later in 2024, the Dr. Pen resellers also stopped selling to the general public. They had a statement on their websites saying that they could only sell to you if you were a licensed medical professional. This is what really caught my attention when I did previous videos on the topic.
This created a situation where many of us thought the FDA was banning them at that time, and almost all websites stopped selling them – except for Temu. I’ll touch more on that in a bit.
So the only option I knew of was to purchase from Temu, not knowing if we’d have any future opportunities to stock up on the cartridges. And, when buying from Temu, you didn’t know if you were buying official Dr. Pen products.
Since then, sometime this year, websites and resellers started selling Dr. Pen products again. Maybe the FDA loosened the reins, but there’s no public statement about what’s going on. There are some microneedling pens being sold on Amazon, but I haven’t seen any by the official brand Dr. Pen.
So, we can assume the situation is still ongoing. But there has been a very recent update from the FDA – and it’s about RF microneedling and the potential risks involved.
A New FDA Warning – But It’s About RF Microneedling
On October 15, 2025, the FDA released a new safety communication, but it wasn’t about regular microneedling pens. It was about RF microneedling devices (radiofrequency microneedling).
These are the ones that use tiny needles to deliver radiofrequency energy into the skin for tightening and resurfacing.
The FDA said they’ve received reports of serious complications with some of these RF devices, including burns, fat loss, scarring, nerve damage, and even disfigurement requiring surgery. They also emphasized that RF microneedling is a medical procedure, not a cosmetic treatment, and that these devices should never be used at home.
You can read the official FDA safety communication here:
Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling – FDA Safety Communication
The Good News – Where You Can Buy Authentic Dr. Pen Devices
You can now buy authentic Dr. Pen devices again through authorized resellers. The one that I’ve recently purchased from is MTP Skin Tech. They’re an official, verified reseller for Ekai, the manufacturer of Dr. Pen. Their products are high-quality, they have good prices, things are well-packaged, and they’re fully transparent about being an authorized source. You can use my code LIFEDIY for 8% off site-wide.
For full disclosure, I’ve been contacted by so many microneedling companies that want me to promote them and I’ve always said no in the past. I just didn’t trust them and I don’t think any of them were official resellers. I’ve had a very positive experience so far with MTP Skin Tech, and I am now an affiliate with them, which means if you purchase through my link, I may earn a small commission at no extra cost to you. I only recommend them because I’ve verified they’re an official, authorized reseller for Dr. Pen, and I’ve personally ordered from them myself. If anything changes in the future, I will let you know with updates.
I’ve purchased from Temu in the past too when options were limited, and if you prefer to buy there you can use my code “acn120083” for 30% off, but there is now way of knowing if the products are authentic. And, I tried my best to verify where the products were made – I contacted numerous brands and potential manufacturers but they never got back to me. So, I could never verify if the products were officially made by Ekai. But, it’s worth noting that I never had any issues with them at all. So, Temu is still an option. Before purchasing cartridges anywhere, I recommend checking out my post: Before Buying Microneedling Pens and Cartridges – Check Out the Closeups 1st!
Latest Dr. Pen Innovation: The New Hydra Pen H6
Lastly, I wanted to share that I just got the Hydra Pen H6. It is the newest official Dr. Pen device, and I bought it from MTP Skin Tech. I’ll be testing it out and sharing a full video on how it works soon. Make sure you subscribe to Life & DIY on Youtube for updates.
What makes this one different is that it’s not just a microneedling pen – it also dispenses serum directly into your skin while you needle. You can fill the top compartment with your serum, and it’s released evenly through the tip during treatment. I haven’t used it yet but will be doing a first impressions video really soon.
I’m excited to test it out and show exactly how it works, and how it compares to some of the earlier Dr. Pen models I’ve used in the past. If you’re subscribed to my YouTube channel, make sure you have notifications on, because that full demo and first-impressions video will be coming soon.
