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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device

Tenderneeds Fertility LLC: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Agency Publication Date: August 2, 2021
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Affected Products

Product: Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001

All lots sold prior to December 9, 2019.

Product: Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt

All lots sold prior to December 9, 2019.

Product: Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

All lots sold prior to December 9, 2019.

Product: Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

All lots sold prior to December 9, 2019.

Product: 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960

All lots sold prior to December 9, 2019.

Product: TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771

All lots sold prior to December 9, 2019.

Product: Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856

All lots sold prior to December 9, 2019.

Product: Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

All lots sold prior to December 9, 2019.

Product: 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown

All lots sold prior to December 9, 2019.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88225
Status: Active
Manufacturer: Tenderneeds Fertility LLC
Manufactured In: United States
Units Affected: 9 products (Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown; Unknown)

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

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This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.