Tenderneeds Fertility Insemination Kit Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling its Premium At Home Pro Series Insemination Kit because it was distributed without proper 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: The recall is classified as FDA Class II, but the source text indicates the issue is a regulatory compliance failure (lack of marketing authorization) rather than a direct physical hazard or reported injury, fitting the criteria for a moderate severity voluntary or compliance-driven recall.
Plain-English summary
Tenderneeds Fertility LLC is recalling the Premium At Home Pro Series Insemination Kit (SKU 644042787927). The recall was initiated because the device was distributed without a proper marketing authorization.
The recall applies to all lots of the product. The device was distributed worldwide.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Premium At Home Pro Series Insemination Kit (SKU 644042787927)
- Manufacturer
- Tenderneeds Fertility LLC
- Category
- Medical Device — Fertility
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 (1)
- All lots
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 10 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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