FDA Recalls IUI Kit and Metal Speculum for Lacking Marketing Authorization
Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.
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: FDA Class II recall for regulatory non-compliance: the device was distributed without the required marketing authorization. No adverse events or patient injuries are reported in the source material.
Plain-English summary
Tenderneeds Fertility LLC is recalling the Premium Human Artificial Intrauterine Insemination (IUI) Kit and Metal Speculum, SKU 636391205887. The device was distributed without the required FDA marketing authorization.
The recall affects all lots sold prior to December 9, 2019, and the products were distributed worldwide. This is a Class II recall and represents an expansion of previous FDA recall actions (RES 87581, Z-1355-2021 through Z-1364-2021).
The recalled product
- Product
- Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
- 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 (2)
- All lots sold prior to December 9
- 2019.
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 9 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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