Reported Aug 11, 2021 · Ongoing

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

Tenderneeds Fertility LLC

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Tenderneeds Fertility LLC · 10162 Bradford Rd · Greenville, IN · 47124-9227

Is this the product you have?

  • 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Lot codes and dates
    • All lots sold prior to December 9
    • 2019
Amount recalled
Unknown

This recall covers 9 products

The agency filed one notice per product. You are reading one of them; the other 8 are below.

Why it was recalled

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

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:17 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.