Tenderneeds Fertility Recalls At-Home Insemination Set for Lack of Authorization
Tenderneeds Fertility LLC is recalling its Professional At Home Artificial Intrauterine Insemination Set 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 does not report any illnesses, injuries, or hospitalizations. The hazard is regulatory (lack of authorization) rather than a direct physical defect causing harm, fitting the criteria for a moderate severity score.
Plain-English summary
Tenderneeds Fertility LLC is recalling the Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811). The recall was initiated because the device was distributed without a proper marketing authorization.
The recall covers all lots of the product, which was distributed worldwide. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers who have purchased this product should stop using it and contact the recalling firm for instructions on how to return the device or obtain a refund.
The recalled product
- Product
- Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811)
- 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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