Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Flex Set
Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set because it was distributed without proper 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: 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, aligning with the 'Moderate' criteria for minor or procedural issues.
Plain-English summary
Tenderneeds Fertility LLC is recalling the At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870). 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 U.S. Food and Drug Administration has classified this as a Class II recall.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870)
- 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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