Tenderneeds Fertility LLC recalls unapproved At Home Artificial Intrauterine Insemination Kits due to lack of proper marketing authorization. Affected kits include specific SKUs and all lots. Consumers should contact the company for details.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility LLC is recalling certain At Home Artificial Intrauterine Insemination Kits because they were distributed without proper medical approval. This recall affects users who may have purchased these kits and could pose risks related to unapproved medical devices.
The kits were distributed without proper marketing authorization, meaning they lack required medical safety and regulatory approvals. This could lead to improper use or potential health risks if the devices are not designed for medical use.
Women seeking fertility treatments who purchased the recalled kits are affected. Those using the kits without proper medical authorization may be at higher risk.
Check for the specific SKUs listed: 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801. All lots of these kits are affected.
Identify the specific SKU number on the kit packaging to confirm if it is among the recalled SKUs.
The kits were distributed without proper marketing authorization, meaning they lack required medical safety and regulatory approvals.
The official recall notice does not specify a remedy or action steps beyond checking the SKU number.
Yes, all lots of the specific SKUs listed are affected by this recall.
We’ve drafted a message you can send Tenderneeds to request your refund or repair — edit it as you like.
Subject: Recall Z-1355-2021 — Tenderneeds Tenderneeds Hello, I own a Tenderneeds that is covered by recall Z-1355-2021 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.
