Tenderneeds Fertility LLC recalls its Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) due to distribution without proper marketing authorization. All units are affected.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility has recalled all units of its Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) because it was distributed without proper marketing authorization. This means the product may not meet safety or regulatory standards, potentially affecting users' health.
The device was distributed without proper marketing authorization, meaning it may not meet safety or regulatory standards. This could lead to health risks if the product is used without appropriate oversight.
Users of the Professional At Home Artificial Intrauterine Insemination Set are affected. Pregnant individuals or those undergoing fertility treatments may be at higher risk due to potential regulatory issues.
Check for the SKU 644042787811 on the product. All lots of this device are affected by the recall.
Look for the SKU 644042787811 on the device to confirm it is affected.
The recall states the device was distributed without proper marketing authorization, so it may not meet safety standards. The official notice does not specify if it is safe to use.
Check for the SKU 644042787811 on the product. All lots of this device are affected by the recall.
The recall does not specify a remedy, so the official notice does not state what action to take.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-1364-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-1364-2021 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.
