Tenderneeds Fertility LLC recalls all Premium At Home Pro Series Insemination Kits (SKU : 644042787927) due to distribution without proper marketing authorization. No remedy specified in official notice.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility LLC is recalling all Premium At Home Pro Series Insemination Kits (SKU 644042787927) because they were distributed without proper marketing authorization. This recall does not pose a direct safety risk to users but is a regulatory compliance issue.
The device was distributed without proper marketing authorization, meaning it may not meet regulatory standards for safety or effectiveness. However, the recall does not indicate a physical hazard or risk of injury to users.
Owners of the Premium At Home Pro Series Insemination Kit (SKU 644042787927) are affected. Most at risk are individuals using this product for fertility treatments who may not be aware of the regulatory status.
Check for the SKU number 644042787927 on the product packaging. All lots of this specific insemination kit are affected by the recall.
Verify the SKU number 644042787927 on the packaging to confirm if your kit is affected.
The recall is due to regulatory compliance, not a safety hazard. The product is not considered dangerous to use.
The official notice does not specify a remedy, so no action is required beyond checking if your product is affected.
No injury risk is mentioned in the recall. The hazard is regulatory, not physical.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-1360-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-1360-2021 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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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.
