Tenderneeds Fertility Deluxe At Home Artificial Insemination Kit Recall: Missing Marketing Authorization

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Contact the company & request your remedy

Recalling firmTenderneeds Fertility LLC10162 Bradford Rd, N/A · Greenville, IN 47124-9227

No email on file — write to the address above instead.

✎ GovInfoNow plain-language explainer

What happened, in plain English

Tenderneeds Fertility is recalling all Deluxe At Home Artificial Insemination Kits (SKU 636391205832) because they were distributed without proper marketing authorization. This means the product may not meet regulatory safety standards, though no specific harm or remedy is mentioned in the recall.

Why it’s dangerous

The product was distributed without proper marketing authorization, which means it may not meet safety or quality standards set by regulatory authorities. This could potentially lead to issues with the product's effectiveness or safety, though the recall does not specify any actual harm or injury.

Who’s affected

Anyone who owns or uses the Deluxe At Home Artificial Insemination Kit (SKU 636391205832) is affected. The highest risk group is likely those using the kit for fertility treatments without proper regulatory oversight.

How to tell if you have this one

Check for the product name 'Deluxe At Home Artificial Insemination Kit' and the SKU number 636391205832. All lots of this product are included in the recall.

Brand
Tenderneeds Fertility
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Product Details
Identify the product name and SKU number to confirm if it is recalled.

✎ GovInfoNow

Questions people ask

Is there a specific remedy for this recall?

The recall notice does not state any remedy or action required.

Why was this product recalled?

The product was distributed without proper marketing authorization.

How can I tell if I have the recalled product?

Look for the product name 'Deluxe At Home Artificial Insemination Kit' and SKU 636391205832.

Take action

Contact Tenderneeds Fertility

We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1359-2021 — Tenderneeds Fertility Tenderneeds Fertility

Hello,

I own a Tenderneeds Fertility that is covered by recall Z-1359-2021 from Tenderneeds Fertility.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1359-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1359-2021 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Tenderneeds Fertility LLC recalls Deluxe At Home Artificial Insemination Kit (SKU 636391205832)

Recall notice