Tenderneeds Fertility Recalls At Home Artificial Intrauterine Insemination Kits
Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits because they were 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, which typically corresponds to a moderate severity score. The hazard is a regulatory compliance issue (lack of marketing authorization) rather than a direct physical injury or illness, and no adverse events are reported in the source text.
Plain-English summary
Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kits. The recall involves specific SKUs, including 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801.
The recall was initiated because the device was distributed without a proper marketing authorization. The source text does not specify the number of units affected or the specific dates of distribution.
The product was distributed worldwide. Consumers who have purchased these kits should stop using them and contact the manufacturer for further instructions.
The recalled product
- Product
- At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
- 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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