Tenderneeds Insemination Device Recalled for Lack of Marketing Authorization
Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device 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. The hazard is a regulatory compliance issue (lack of marketing authorization) rather than a direct physical defect or contamination, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Tenderneeds Fertility LLC is recalling the At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903). The recall was initiated because the device was distributed without a proper marketing authorization.
The recall covers all lots of the product, which had world-wide distribution. The source text does not specify the number of units affected or the specific geographic regions where the product was sold.
Consumers who have this product should stop using it and contact the recalling firm for further instructions. The source text does not provide specific contact details or a return address.
The recalled product
- Product
- At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903)
- 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 (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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