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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
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.
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