Tenderneeds Fertility recalls Deluxe At-Home ICI Insemination Kit (SKU 636391205856) sold before Dec 9, 2019 due to lack of proper marketing authorization.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Tenderneeds Fertility is recalling a specific at-home fertility kit sold before December 9, 2019 because it was distributed without proper regulatory approval. This means the product may not meet safety standards for use.
The product was distributed without proper regulatory approval, which means it may not meet safety standards for use. This could lead to potential risks if the product is used without proper oversight.
People who purchased this specific fertility kit before December 9, 2019 are affected. Those using the product for fertility treatments may be at higher risk due to unapproved marketing.
Check for the SKU number 636391205856 on the kit. The product was sold before December 9, 2019.
Look for the SKU number 636391205856 and verify the purchase date was before December 9, 2019.
The recall states the product was distributed without proper marketing authorization, but does not specify if it is safe to use.
The recall does not provide specific action steps for affected consumers.
The product was sold before December 9, 2019.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-2181-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-2181-2021 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.
