Tenderneeds Fertility recalls unapproved At Home Artificial Intrauterine Insemination Flex Set (SKU 636:391205870) due to lack of proper marketing authorization. No specific action steps provided in recall notice.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility is recalling all units of their At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) because it was distributed without proper marketing authorization. This means the product may not meet safety standards for medical use.
The device was distributed without proper marketing authorization, meaning it may not meet safety standards for medical use. This could lead to improper treatment outcomes or complications during fertility procedures.
Women using this fertility treatment device are likely affected. Those with medical conditions requiring precise device handling may be at higher risk.
Check for the SKU 636391205870 on the product packaging. All lots of this device are included in the recall.
Look for the SKU 636391205870 on the packaging to confirm if the device is recalled.
The recall notice does not specify any action steps for consumers.
The device was distributed without proper marketing authorization.
Check for the SKU 636391205870 on the product packaging. All lots are included in the recall.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-1357-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-1357-2021 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
