Tenderneeds Fertility recalls unapproved Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) due to lack of proper marketing authorization. All lots affected.
Device was distributed without a proper marketing authorization.
Tenderneeds Fertility is recalling all versions of their Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) because it was distributed without proper marketing authorization. This means the product may not meet safety or regulatory standards.
The kit was distributed without proper marketing authorization, meaning it may not meet safety or regulatory standards. This could lead to potential risks during fertility treatments, though specific hazards aren't detailed in the recall.
Women using fertility treatments with this kit may be affected. Those who have purchased the product are most at risk.
Check for the SKU 636391205986 on the kit. All lots of this product are affected, so no specific model or date range is listed.
Look for the SKU 636391205986 on the kit to confirm it's affected.
The recall states the kit was distributed without proper marketing authorization, but does not specify if it's safe to use.
The recall does not mention any remedy or replacement options.
The recall does not specify a remedy, so you should contact Tenderneeds Fertility directly for guidance.
We’ve drafted a message you can send Tenderneeds Fertility to request your refund or repair — edit it as you like.
Subject: Recall Z-1361-2021 — Tenderneeds Fertility Tenderneeds Fertility Hello, I own a Tenderneeds Fertility that is covered by recall Z-1361-2021 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.
