Greenville, IN, United States
Tenderneeds Fertility LLC recalls
2 recalls recorded since 2018, most recently on 23 December 2020. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)2
Terminated or completed0
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 23 December 2020
- Reason
- Device was distributed without a proper marketing authorization.
- Distribution
- World-wide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-1356-2021, Z-1358-2021, Z-1360-2021, Z-1355-2021, Z-1362-2021, Z-1357-2021, Z-1364-2021, Z-1359-2021, Z-1361-2021, Z-1363-2021
- At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
- Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
- Premium At Home Pro Series Insemination Kit (SKU 644042787927)
- At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
- Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
- At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
- Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
- Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
- and 2 more product lines
Ongoing Class II Medical devices
- Recall started
- 23 December 2020
- Reason
- Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
- Distribution
- Worldwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-2182-2021, Z-2178-2021, Z-2175-2021, Z-2177-2021, Z-2181-2021, Z-2176-2021, Z-2183-2021, Z-2180-2021, Z-2179-2021
- Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
- Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
- Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
- Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
- Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
- 2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
- TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
- and 1 more product lines
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.