I have had my listing blocked for the reason of it being a class 2a medical device. My question is what documents do I need to submit on my appeal to have the ASIN reinstated as there are other sellers listing the exact same product for over 12 months and in regards to these amazon say no violation has been identified. My product is the same as theirs from the same brand and supplier. please help

Hi everyone,

I'm facing an ongoing issue with Amazon incorrectly classifying our product—a Suture Practice Kit—as containing surgical clamps, medical forceps, and hypodermic needles, leading to its removal from Amazon.co.uk.

Key Points: The tools in the kit are non-sterile, non-medical-grade, and explicitly intended for educational practice only on synthetic models. They are unsuitable for use on humans or animals, as clearly stated in our packaging and instructions disclaimers. However, Amazon’s automated system keeps flagging our product as prohibited surgical tools. This misclassification is based on appearance, not function. We've tried to explain that other products resembling prohibited items are allowed on Amazon because they serve a different purpose than the real item. Our educational tools fall into the same category—they resemble surgical tools but are clearly labeled and designed (different size, materials, etc.) for training only.

The Official organ that regulates medical devices in the UK agreed with us in our email correspondence and clearly stated that our product is not a medical device because it doesn't meet the requirements to be considered one (medical devices either treat, prevent, or diagnose a disease).

We've appealed multiple times but keep receiving the same automated response. I’m seeking a solution that includes manual review by Amazon staff, as the automated process isn’t identifying the true nature of the product.

Any advice or support would be appreciated!

I’ve noticed that sellers are listing unlicensed medical devices on amazon. Im the owner of a correctly licensed product to treat a medical condition and I am aware of the strict regulations. Ive reported some listings but Amazon don’t bother to remove them. The most recent one I have reported is ASIN is B0CF2RF6JH and as you can see it’s still there weeks later.

To list this is breaking the law as they have to be licensed and tested according to FDA regulations to ensure product safety.

I wondered if this was a common occurrence- ie are Amazon knowingly allowing unlicensed medical devices to be sold on their marketplace? I’m gathering evidence for an FDA case outlining Amazon’s stance on this subject and it would help to have other sellers experiences if applicable. Please could others reply with the ASIN in question so that we can include it if similar contravention applies.

Thank you