Tenderneeds Fertility LLC At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Brand
Tenderneeds Fertility LLC
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Tenderneeds Fertility LLC is recalling At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 6363 due to Device was distributed without a proper marketing authorization.. 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.
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.
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