Reported Apr 14, 2021 · Ongoing

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

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?

  • Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Lot codes and dates
  • All lots
Amount recalled
Unknown

This recall covers 10 products

The agency filed one notice per product. You are reading one of them; the other 9 are below.

Why it was recalled

Device was distributed without a proper marketing authorization.

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, 5:43 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.