Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization
Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.
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: This is a risk-of-harm product—an unapproved medical device for human reproduction distributed without FDA marketing authorization. No illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products without reported injury.
Plain-English summary
Tenderneeds Fertility LLC is recalling the 2 X Sterile Human Home Artificial Insemination Semen Kit (SKU 143298592960). The U.S. Food and Drug Administration has classified this as a Class II recall.
The device was distributed without the proper marketing authorization required by the FDA. All affected units were distributed prior to December 9, 2019, with distribution occurring worldwide.
This recall is part of an expansion of previous enforcement actions related to unauthorized distribution of similar devices.
The recalled product
- Product
- 2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
- 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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