Tenderneeds Fertility LLC Recalls Deluxe At Home Artificial Insemination Kit
Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial 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 due to a regulatory compliance issue (lack of marketing authorization) rather than a direct physical hazard or reported injury, fitting the criteria for moderate severity.
Plain-English summary
Tenderneeds Fertility LLC is recalling the Deluxe At Home Artificial Insemination Kit (SKU 636391205832). The recall was initiated because the device was distributed without a proper marketing authorization.
The affected product was distributed worldwide. All lots are included in this recall. The U.S. Food and Drug Administration has classified this as a Class II recall.
Consumers who have this product should stop using it and contact the recalling firm for instructions on how to return or dispose of the device.
The recalled product
- Product
- Deluxe At Home Artificial Insemination Kit (SKU 636391205832)
- 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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