Tenderneeds Fertility Recalls Insemination Kits Lacking Marketing Authorization
Tenderneeds Fertility LLC is recalling Professional Clinical 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, but the source text cites a lack of marketing authorization rather than a specific safety defect or reported injury, aligning with a moderate severity for regulatory non-compliance.
Plain-English summary
Tenderneeds Fertility LLC is recalling Professional Clinical Artificial Intrauterine Insemination Kits (SKUs 636391205962 and 636391206013). The recall covers all lots of the product, which has been distributed worldwide.
The recall was initiated because the device was distributed without a proper marketing authorization. This is a regulatory compliance issue rather than a report of specific product defects or adverse health events.
Consumers and healthcare providers who have these kits should stop using them and contact the recalling firm for further instructions.
The recalled product
- Product
- Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)
- 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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