Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Tenderneeds Fertility with 19 device recalls. The most recent is a device recall dated Dec 23, 2020: Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Dec 23, 2020 | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046Class II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSWClass II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001Class II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887Class II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856Class II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuiktClass II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknownClass II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
| Dec 23, 2020 | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771Class II · Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 th | Device recalls |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
