Tenderneeds recalls 2 Complete ICI Human At Home Donor Artificial Insemination Kits sold before Dec 9, 2019 due to lack of proper marketing authorization. No remedy specified in official notice.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Tenderneeds is recalling certain fertility kits sold before December 9, 2019 because they were distributed without proper medical approval. This affects people using these kits for donor artificial insemination.
The kits were distributed without proper medical authorization, meaning they may not meet safety and effectiveness standards. This could lead to health risks if used without proper oversight.
People who purchased the kits from Tenderneeds before December 9, 2019 are affected. Those using donor artificial insemination with these kits are at risk.
Check for Tenderneeds Fertility kits with SKU unknown sold before December 9, 2019. The product name is '2 Complete ICI Human At Home Donor Artificial Insemination Kits'.
Verify if your kit was sold before December 9, 2019 by checking the purchase date or packaging.
The kits were distributed without proper marketing authorization, which means they lack required medical approval.
The official notice does not specify a remedy, so there is no instruction to stop using them.
The official notice does not provide specific action steps for affected consumers.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-2183-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-2183-2021 from Tenderneeds. 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.
