FDA (Devices) recall action 87581

Tenderneeds Fertility LLC recalled 10 products on 2021-04-14

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.

Products: 10
Announced: 2021-04-14
Critical: 0
Units: —

Why these products were recalled

Device was distributed without a proper marketing authorization.

The agency’s own wording, quoted from the enforcement report.

1–10 of 10

ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits
Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.
Product
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Pro Series Fertility Device Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling the Pro Series Fertility Device because it was distributed without proper marketing authorization.
Product
Pro Series Fertility Device (SKU 644042788139)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Insemination Kit Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling its Premium At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Product
Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization
Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set because it was distributed without proper marketing authorization.
Product
Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit
Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit because it was distributed without proper marketing authorization.
Product
Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility LLC Recalls Deluxe At Home Pro Series Insemination Kit
Tenderneeds Fertility LLC is recalling the Deluxe At Home Pro Series Insemination Kit because it was distributed without proper marketing authorization.
Product
Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device because it was distributed without proper marketing authorization.
Product
At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set
Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper marketing authorization.
Product
At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization
Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits because they were distributed without proper marketing authorization.
Product
Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Category
Distribution
0 states
ModerateFDA (Devices)··2021-04-14
Tenderneeds Fertility Recalls Professional Artificial Intrauterine Insemination Kit
Tenderneeds Fertility LLC is recalling its Professional Artificial Intrauterine Insemination Kit because it was distributed without proper marketing authorization.
Product
Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
Category
Distribution
0 states