Tenderneeds Fertility LLC: Medical Device Recall in 2021 - (Recall #: Z-1355-2021)

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:

At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)

Product Classification:

Class II

Date Initiated: December 23, 2020

Date Posted: April 14, 2021

Recall Number: Z-1355-2021

Event ID: 87581

Reason for Recall:

Device was distributed without a proper marketing authorization.

Status: Ongoing

Product Quantity: Unknown

Code Information:

All lots

Distribution Pattern:

World-wide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated