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Tenderneeds Fertility Recalls
19 recalls on record · April 14, 2021 to August 11, 2021 · Medical Devices
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
August 11, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Hazard: Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Pro Series Fertility Device (SKU 644042788139)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Professional Artificial Intrauterine Insemination Kit (SKU 636391205986)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Premium At Home Pro Series Insemination Kit (SKU 644042787927)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
Hazard: Device was distributed without a proper marketing authorization.
April 14, 2021Medical DevicesFDA
Tenderneeds Fertility LLC recalls At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 6363912058
Hazard: Device was distributed without a proper marketing authorization.