Tenderneeds recalls all Ultimate Fertility At Home Insemination Kits with Sperm Wash Medium (SKU ULTFKSW) 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 is recalling all Ultimate Fertility At Home Insemination Kits with Sperm Wash Medium sold before December 9, 2019 because they were distributed without proper marketing authorization. This means the product may not meet safety standards and could pose risks to users.
The product was distributed without proper marketing authorization, which means it may not meet safety standards. This could lead to potential risks during use, though the exact nature of the hazard isn't specified in the recall notice.
People who purchased the Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium (SKU ULTFKSW) before December 9, 2019 are affected. Those using the product for fertility treatments are most at risk.
Check for the SKU ULTFKSW on the product label. The kit was sold before December 9, 2019. The product name is Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium.
Look for the SKU ULTFKSW on the product label to confirm it was sold before December 9, 2019.
The product was distributed without proper marketing authorization, which is an expansion of previous regulatory actions.
The recall notice does not specify a remedy, so you should check the product details to see if it was sold before December 9, 2019.
The recall states the product was distributed without proper marketing authorization, but does not describe specific injury risks.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-2178-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-2178-2021 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.
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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.
