Tenderneeds Fertility LLC Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Brand
Tenderneeds Fertility LLC
Lot Codes / Batch Numbers
All lots sold prior to December 9, 2019.
Products Sold
All lots sold prior to December 9, 2019.
Tenderneeds Fertility LLC is recalling Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046 due to Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Recommended Action
Per FDA guidance
On December 23, 2020, the firm published a recall notification on its website at the following URL: https://tenderneedsfertility.com/recalls. The notification notified customers that all IUI and ICI kits sold for human use were being recalled. Customers were instructed to destroy these products, including leftover portions, immediately. The firm did not ask customers to return the product. This event was previously recorded under RES 87851. On June 9, 2021, firm updated recall communication on website to include more information about the recall. All IUI and ICI kits sold for human use by the firm prior to December 9, 2019 are subject to the recall. Some of the products listed in the notice were not previously captured by FDA's summary. This event (RES 88225) was created to document these additional products.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026