Tenderneeds Fertility recalls IUI kits and metal speculums sold before Dec 9, 2019 due to lack of proper medical authorization. No immediate action needed but check your product.
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 IUI kits and metal speculums sold before December 9, 2019 because they were distributed without proper medical approval. This affects people using these products for fertility treatments.
The devices were distributed without proper medical authorization, which means they may not meet safety standards. This could lead to potential issues during medical procedures but does not indicate immediate danger.
People who purchased the Tenderneeds IUI kits or metal speculums before December 9, 2019 are likely affected. Those using these products for fertility treatments are at most risk.
Check for the SKU 636391205887 on the product packaging. The recall covers all units sold before December 9, 2019.
Look for the SKU 636391205887 on the packaging to confirm if your product is affected.
The recall is due to lack of proper medical authorization, but the devices do not pose an immediate risk. No action is needed beyond checking your product.
No action is required. The recall does not mandate stopping use, but you should check if your product is affected.
The affected products were 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-2177-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-2177-2021 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.
