TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization
TenderNeeds Fertility PRO IUI home insemination kits were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019, are affected.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II devices distributed without proper marketing authorization represent a regulatory violation with potential for harm. However, the source text contains no reports of illnesses, injuries, or deaths, placing this recall in the 'risk-of-harm' category where injury has not yet been reported.
Plain-English summary
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits (SKU 133166055771) are subject to a recall. The kits were manufactured by Tenderneeds Fertility LLC and distributed worldwide.
The devices were distributed without the proper FDA marketing authorization required before such products are sold to consumers. This recall represents an expansion of previous FDA enforcement actions (RES 87581, Z-1355-2021 through Z-1364-2021) related to unauthorized device distribution.
All lots of these kits distributed prior to December 9, 2019, are included in this recall.
The recalled product
- Product
- TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
- Manufacturer
- Tenderneeds Fertility LLC
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All lots sold prior to December 9
- 2019.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 recalled by Tenderneeds Fertility LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 9 products in this recall →Related recalls
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