Tenderneeds Fertility LLC

FDA Regulatory Profile

Summary

Total Recalls
19
510(k) Clearances
0
Inspections
2
Compliance Actions
1

Recent Recalls

NumberClassProductDate
Z-2177-2021Class IIPremium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887December 23, 2020
Z-2175-2021Class IIFlex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001December 23, 2020
Z-2176-2021Class IIHome Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuiktDecember 23, 2020
Z-2178-2021Class IIUltimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSWDecember 23, 2020
Z-1361-2021Class IIProfessional Artificial Intrauterine Insemination Kit (SKU 636391205986)December 23, 2020
Z-2180-2021Class IITenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771December 23, 2020
Z-2179-2021Class II2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960December 23, 2020
Z-2182-2021Class IIDeluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046December 23, 2020
Z-2183-2021Class II2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknownDecember 23, 2020
Z-2181-2021Class IIDeluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation TestDecember 23, 2020
Z-1355-2021Class IIAt Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 6363December 23, 2020
Z-1362-2021Class IIProfessional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)December 23, 2020
Z-1356-2021Class IIAt Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)December 23, 2020
Z-1357-2021Class IIAt Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)December 23, 2020
Z-1364-2021Class IIProfessional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)December 23, 2020
Z-1359-2021Class IIDeluxe At Home Artificial Insemination Kit (SKU 636391205832)December 23, 2020
Z-1358-2021Class IIDeluxe At Home Pro Series Insemination Kit (SKU 644042787958)December 23, 2020
Z-1360-2021Class IIPremium At Home Pro Series Insemination Kit (SKU 644042787927)December 23, 2020
Z-1363-2021Class IIPro Series Fertility Device (SKU 644042788139)December 23, 2020