FDAClass IIAugust 11, 2021

Ultimate Fertility At Home Insemination Kit with Sperm recall

Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Why was Ultimate Fertility At Home Insemination Kit with Sperm recalled?

Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All lots sold prior to December 9, 2019.

Product
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Recalling firm
Tenderneeds Fertility LLC
Quantity
Unknown
Distribution
Worldwide distribution.
Recall date
August 11, 2021
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls