Tenderneeds Fertility PRO IUI Human Artificial Insemination Kits (SKU 133166055771) sold before Dec 9, 2019 were distributed without proper marketing authorization. Affected users should contact the manufacturer for details.
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 insemination kits sold before December 9, 2019 due to being distributed without proper marketing authorization. This means the kits may not meet safety or regulatory standards, though no injuries have been reported.
The kits were distributed without proper marketing authorization, meaning they may not meet safety or regulatory standards. This could lead to improper use or failure in fertility treatments, though no injuries have been reported.
Users of Tenderneeds Fertility PRO IUI kits with SKU 133166055771 purchased before December 9, 2019 are affected. Individuals using these kits for fertility treatments are most at risk due to potential regulatory non-compliance.
Check for the SKU 133166055771 on the kit packaging. Products sold before December 9, 2019 are affected.
Verify the SKU number and purchase date on the kit packaging.
The kits were distributed without proper marketing authorization, which may mean they don't meet safety or regulatory standards.
Contact Tenderneeds Fertility directly for details on next steps, as the recall remedy is not specified in the record.
No injuries have been reported in this recall.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-2180-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-2180-2021 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.
