Tenderneeds Fertility LLC
FDA Regulatory Profile
Tenderneeds Fertility LLC has 19 FDA recalls, 2 inspections, 0 510(k) clearances and 1 compliance action on record.
- Latest recall
- Z-2175-2021 · Class II · Dec 23, 2020
- Latest inspection
- Sep 29, 2021 · OAI
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Summary
Record counts and when each FDA source was last refreshed
| Records | Count | Last refreshed | Source as of | Status |
|---|
| Recalls | 19 | Nov 4, 2026 (checked Nov 8, 2026, unchanged) | File dated Nov 3, 2026 | Current |
|---|
| 510(k) clearances | 0 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
|---|
| Inspections | 2 | Nov 9, 2026 | Newest record Oct 28, 2026 | Current |
|---|
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
|---|
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2175-2021 | Class II | Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 | Dec 23, 2020 |
| Z-2181-2021 | Class II | Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation… | Dec 23, 2020 |
| Z-2177-2021 | Class II | Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887 | Dec 23, 2020 |
| Z-2183-2021 | Class II | 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown | Dec 23, 2020 |
| Z-2180-2021 | Class II | TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771 | Dec 23, 2020 |
| Z-1363-2021 | Class II | Pro Series Fertility Device (SKU 644042788139) | Dec 23, 2020 |
| Z-2179-2021 | Class II | 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960 | Dec 23, 2020 |
| Z-2182-2021 | Class II | Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 | Dec 23, 2020 |
| Z-1362-2021 | Class II | Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013) | Dec 23, 2020 |
| Z-1355-2021 | Class II | At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900… | Dec 23, 2020 |
| Z-2176-2021 | Class II | Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt | Dec 23, 2020 |
| Z-2178-2021 | Class II | Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW | Dec 23, 2020 |
| Z-1358-2021 | Class II | Deluxe At Home Pro Series Insemination Kit (SKU 644042787958) | Dec 23, 2020 |
| Z-1356-2021 | Class II | At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) | Dec 23, 2020 |
| Z-1359-2021 | Class II | Deluxe At Home Artificial Insemination Kit (SKU 636391205832) | Dec 23, 2020 |
| Z-1357-2021 | Class II | At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870) | Dec 23, 2020 |
| Z-1361-2021 | Class II | Professional Artificial Intrauterine Insemination Kit (SKU 636391205986) | Dec 23, 2020 |
| Z-1360-2021 | Class II | Premium At Home Pro Series Insemination Kit (SKU 644042787927) | Dec 23, 2020 |
| Z-1364-2021 | Class II | Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811) | Dec 23, 2020 |
Recent FDA Inspections
NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.
FDA-Inspected Facilities
| Facility | Location | Inspections | Latest |
|---|
| FEI 3012228225 | Greenville, IN | 2 | Sep 29, 2021 |