Tenderneeds Fertility LLC recalls all At Home Semi-Flex/Rigid Insemination Devices (SKU 644042787903) 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 At Home Semi-Flex/Rigid Insemination Devices (SKU 644042787903) because they were distributed without proper marketing authorization. This recall does not involve a safety hazard but addresses regulatory compliance issues.
The device was distributed without proper marketing authorization, meaning it may not meet regulatory standards for medical devices. This could lead to compliance issues but does not inherently pose a safety risk like physical harm or injury.
People who own or use the At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) are affected. Those most at risk are individuals using the device for medical purposes without proper regulatory approval.
Check for the SKU 644042787903 on the device packaging. All lots of this product are affected by the recall.
Identify the SKU 644042787903 on the product packaging to confirm if it is affected.
The recall is due to distribution without proper marketing authorization, not a safety hazard. The device itself is not considered dangerous under normal use.
The official notice does not specify a remedy, so there is no requirement to stop using the device.
Check for the SKU 644042787903 on the product packaging. All lots of this product are affected.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-1356-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-1356-2021 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.
