Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum Recalled by Tenderneeds Fertility LLC Due to Device was distributed without a proper marketing authorization....

Date: December 23, 2020
Company: Tenderneeds Fertility LLC
Status: Ongoing
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Tenderneeds Fertility LLC directly.

Affected Products

Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

Quantity: Unknown

Why Was This Recalled?

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

Where Was This Sold?

Worldwide distribution.

About Tenderneeds Fertility LLC

Tenderneeds Fertility LLC has 19 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report