Tenderneeds Fertility LLC

Complete recall history across all FDA and CPSC categories — 19 total recalls

Tenderneeds Fertility LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Device Recalls (19)

FDA medical device enforcement actions by Tenderneeds Fertility LLC

Date Product Reason Class
Dec 23, 2020 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 1432985... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 Pro Series Fertility Device (SKU 644042788139) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Deluxe At Home Artificial Insemination Kit (SKU 636391205832) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 13... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, ... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, S... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205... Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205... Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pre... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 Premium At Home Pro Series Insemination Kit (SKU 644042787927) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum... Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW Device was distributed without a proper marketing authorization. This event i... Class II
Dec 23, 2020 At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) Device was distributed without a proper marketing authorization. Class II
Dec 23, 2020 Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 Device was distributed without a proper marketing authorization. This event i... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.

Explore More Recalls

Search recalls by category, state, reason, or firm across all our databases.