Hello Mods,

We have already taken over 1 month since April 29th to have our products safety compliance review. We make a new UL2054 test report for our ASIN B0FB2JYZ1G to submit for review, but still being refused with no specific reason, only saying have been rejected due to missing requirements. We contacted seller support, they can't really give useful help, we still don't know where is missed, missed what.

And since this, it's very hard to proceed, what and how to submit documents that meet your RISC team's standard.

We need RISC point out what should we do to proceed, which documents we should revise, where area we should revise or add contents. Could you help us on this, please? Thanks.

There are 3 ASINS belong to lock picking tool that amazon didn't remove them after getting report

B0DXKYHQQC

B0F2JJ94QX

B0F12FZS56

Dear HAQM Legal Team,

I am writing on behalf of our client, a registered medical device manufacturer and distributor, to formally notify HAQM of the ongoing illegal sale of Class II medical devices on your platform, specifically Nebulizers and Saline for Inhalation - under FDA Product Code CAF.

We have identified numerous listings on HAQM.com for:

1. Prescription-only Nebulizer devices classified under FDA Product Code CAF (Jet and Ultrasonic Mesh)

2. Saline for Inhalation, which is regulated as a Class II prescription-only medical device when intended for inhalation delivery (also under product code CAF).

These illegal listings can be found here:

http://www.haqm.com/gp/bestsellers/industrial/8297518011/ref=pd_zg_hrsr_industrial

Per 21 CFR § 868.5630 and the associated product classification, these devices require:

• An active FDA registration and device listing

• Premarket notification [510(k)] clearance

• Sale and distribution under prescription-use only conditions, as indicated by 21 CFR 801.109

As per FDA guidance document, “Reviewer Guidance for Nebulizers, Metered Dose Inhalers, Spacers and Actuators”

• Nebulizers are a prescription-only medical device

Many of the products currently sold via HAQM Marketplace by third-party sellers:

• Are not registered with the FDA as manufacturers or distributors

• Lack 510(k) clearance for the specific intended use

• Fail to display the required prescription labeling, and

• Are being sold directly to consumers without a prescription, in direct violation of FDA and HAQM Medical Device Policies

As per June 9th, 2025, 128 listings of prescription-only Nebulizers and 21 listings of prescription-only Saline for Inhalation are being sold on HAQM.com.

This presents a significant regulatory violation and a potential public health risk, as consumers are unknowingly purchasing and misusing prescription devices without clinical oversight.

Requested Actions:

We respectfully request that HAQM:

1. Immediately remove all listings of nebulizers and saline for inhalation products marketed under FDA Product Code CAF without verified prescription-use controls;

2. Require all sellers of CAF-classified devices to submit valid FDA establishment registration numbers and 510(k) documentation;

3. Re-implement a manual yank for the Nebulizer category to ensure prescription-only medical devices are not offered to the general public.

We have already provided a list of specific ASINs to the FDA’s allegation of abuse team and abuse-escalation @ haqm.com. This same posting will be sent to HAQM legal. This posting is for record on a public forum as HAQM has been aware of this issue since the FDA first notified them to take action against this dangerous and illegal activity in April 2024.

Please confirm receipt of this notice and outline what steps HAQM intends to take to ensure compliance with applicable U.S. medical device laws.

ASIN: B07NPVQ9LF

This is a microphone designed to be used with a bodypack microphone transmitter. The microphone itself has no way of emitting RF but for some reason it has picked up a safety and compliance violation requesting that an FCC ID be provided. I have explained multiple times in the case that this product does NOT emit RF and, therefore, does not have an FCC ID. I have updated the safety and compliance section to show "Product not capable of emitting radio frequency energy" but still the violation remains and the product is blocked. Why have the option to say the product doesn't emit RF if the field is going to be ignored? I would understand if the field was falsified but this product legitimately does NOT emit RF. I have also removed the word "transmitter" from the title and used "bodypack" instead but still no one resolves the violation.

Can you help? @Seller_GEZPMc4CeQfh6 @Seller_l7Jtck9jxnEA0 @Seller_pAPBCLhysbW5T @Seller_OOVUXZLmb2UEH

Case ID: 17648960251

Hi everyone,

I’m writing this because we’ve hit a brick wall with HAQM support, and I’m wondering if anyone here has dealt with something similar — or knows what we can do.

We’ve encountered a seller who uses false information on their listings and sells a dangerous product. This kind of misrepresentation could lead to fatal consequences in real-life situations.

So, we decided to test it. Twice. Through top independent U.S. labs. The results? A complete mismatch with the advertised specifications.

We submitted multiple complaints — because this isn’t just about unfair competition, it’s about customer safety. People use this product for camping, survival, construction, etc. One failure could cost someone their life.

Here’s what we tried:

- Report a Violation (but 500 characters isn’t enough, and there’s no option to attach lab results)

- Brand Registry > Regulatory Compliance — no proper response, only copy-paste replies about unrelated issues like account health or patents

- Help chat — same outcome, no action taken

- Emails to Regulatory and Product Compliance — no replies at all

We’ve filed formal complaints with both the CPSC and FTC, including lab results and evidence of false advertising. We received confirmation from both agencies that the information has been officially recorded in their systems. We notified HAQM about this — but unfortunately, nothing has changed.

We have all the documentation ready — lab reports, screenshots, order IDs — everything. But it seems like no team at HAQM is even willing to review the evidence or respond meaningfully.

This is a dangerous precedent. If this continues, why should any of us bother following the rules? Or worse — should we start lying on our listings too just to compete? It’s shocking that HAQM allows this, and we’re extremely disappointed.

We’re not going to let this go quietly. We demand accountability.

If HAQM refuses to take this seriously, we are prepared to go

public, involve the media, and bring broader attention to how critical safety issues are being ignored. That seems to be the only thing that gets results.

If anyone here has successfully escalated a safety-related case — or dealt with a seller gaming the system — please share your experience.

Thanks in advance.