FDA (Devices) recall action 87581
The FDA (Devices) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
Device was distributed without a proper marketing authorization.
The agency’s own wording, quoted from the enforcement report.
Tenderneeds Fertility LLC is recalling its Premium At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling the Pro Series Fertility Device because it was distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.
Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.