Tenderneeds Fertility recalls Flex IUI Set with LED Lighted Speculum (SKU fls1001) sold before Dec 9, 2019 due to lack of proper marketing authorization. No specific action steps provided in recall 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 Fertility is recalling Flex IUI sets with LED lighted speculums and test kits sold before December 9, 2019. The recall is due to the product being distributed without proper marketing authorization, which may not be safe for use.
The product was distributed without proper marketing authorization, meaning it may not meet safety standards for medical use. This could lead to improper treatment outcomes or potential harm during fertility procedures.
Women using fertility treatments who purchased the Flex IUI Set with LED Lighted Speculum and Test kit (SKU fls1001) before December 9, 2019 are affected. Those with medical conditions requiring precise fertility monitoring may be at higher risk.
Check for the product name 'Flex IUI Set with LED Lighted Speculum and Test kit' and SKU fls1001. The product was sold before December 9, 2019.
Verify the product name and SKU fls1001 to confirm if it matches the recalled items.
The recall states the product was distributed without proper marketing authorization, but does not specify if it is safe to use. The official notice does not provide details on safety risks.
The recall notice does not provide specific action steps for affected customers. The remedy field is null in the official record.
The recall applies to products sold before December 9, 2019, as stated in the product description.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-2175-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-2175-2021 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.
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.
