Tenderneeds Fertility Deluxe At Home Pro Insemination Kit Recall: Unapproved Marketing

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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 Pro Series Insemination Kits (SKU 644042787958) because they were distributed without proper marketing authorization. This means the product may not meet safety or regulatory standards, though no specific harm has been reported.

Why it’s dangerous

The device was distributed without proper marketing authorization, meaning it may not meet safety or regulatory standards. This could lead to potential issues with the product's safety or effectiveness, though no specific harm has been reported.

Who’s affected

Owners of the Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) are affected. People using this product for insemination purposes are at risk if the device lacks proper regulatory approval.

How to tell if you have this one

Check for the product name 'Deluxe At Home Pro Series Insemination Kit' and the SKU 644042787958. All lots of this product are affected.

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 to confirm if it is affected.

✎ GovInfoNow

Questions people ask

Is there a remedy for this recall?

The official notice does not specify any remedy.

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 Pro Series Insemination Kit' and SKU 644042787958. All lots are affected.

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-1358-2021 — Tenderneeds Fertility Tenderneeds Fertility

Hello,

I own a Tenderneeds Fertility that is covered by recall Z-1358-2021 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-1358-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1358-2021 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 Pro Series Insemination Kit (SKU 644042787958)

Recall notice