Tenderneeds Fertility LLC: Medical Device Recall in 2021 - (Recall #: Z-2182-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046

Product Classification:

Class II

Date Initiated: December 23, 2020

Date Posted: August 11, 2021

Recall Number: Z-2182-2021

Event ID: 88225

Reason for Recall:

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

Status: Ongoing

Product Quantity: Unknown

Code Information:

All lots sold prior to December 9, 2019.

Distribution Pattern:

Worldwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated