Deluxe At-Home ICI Insemination Kit Recalled for Unauthorized Distribution
Tenderneeds Fertility LLC recalls its Deluxe At-Home ICI Insemination Kit (SKU 636391205856), all lots sold before December 9, 2019, due to distribution without FDA marketing authorization.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses, injuries, or deaths. The violation is regulatory—distribution without marketing authorization—rather than a direct identified safety defect. Per the severity rubric, when no illnesses are reported and the hazard is theoretical, the score is at most 3; this regulatory non-compliance without demonstrated direct harm merits a Moderate classification.
Plain-English summary
Tenderneeds Fertility LLC has recalled its Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests (SKU 636391205856). The recall affects all units distributed worldwide that were sold prior to December 9, 2019.
The device was distributed without proper FDA marketing authorization. Medical devices require FDA marketing authorization to ensure they are safe and effective for their intended use.
This recall is an expansion of a prior FDA enforcement action.
The recalled product
- Product
- Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Manufacturer
- Tenderneeds Fertility LLC
- Hazard
- unauthorized-distribution
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.
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