FDA (Devices) recall action 88225
The FDA (Devices) publishes a recall like this one as 9 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 9 pages.
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
The agency’s own wording, quoted from the enforcement report.
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.
Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.
Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.
All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without FDA marketing authorization.
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.
Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to December 9, 2019 are affected.
Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold prior to December 9, 2019.