Tenderneeds Fertility recalls Deluxe IntraCervical Insemination Kits sold before Dec 9, 2019 due to lack of proper marketing authorization. No action needed as the product is unapproved but not dangerous.
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 Deluxe IntraCervical Insemination (ICI) Kits sold before December 9, 2019 because they were distributed without proper marketing authorization. This does not pose a safety risk to users.
The kit was distributed without proper marketing authorization, meaning it lacks regulatory approval for use. This does not create a physical hazard but indicates the product may not meet safety or efficacy standards for medical use.
Users of the Deluxe ICI Kit (3) sold before December 9, 2019. Most at risk are individuals using this kit for fertility treatments without proper regulatory approval.
Check for the SKU 382903096046 on the kit. Products sold before December 9, 2019 are affected.
Verify the SKU number and sale date to confirm if the kit is affected.
No, the product is unapproved but does not pose a physical hazard. It lacks regulatory approval for medical use.
No action is needed as the product is not dangerous. The recall is for regulatory compliance, not safety.
The affected kits were sold before December 9, 2019.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-2182-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-2182-2021 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.
