The Recall Desk
HighFDA (Devices)·Z-2179-2021·Announced 2021-08-11

Sterile Home Artificial Insemination Kits Recalled for Missing FDA Marketing Authorization

Tenderneeds Fertility LLC is recalling sterile home artificial insemination semen kits distributed worldwide prior to December 9, 2019, due to lack of required FDA marketing authorization.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm product—an unapproved medical device for human reproduction distributed without FDA marketing authorization. No illnesses or injuries have been reported, placing this in the High category per the rubric criterion for risk-of-harm products without reported injury.

Plain-English summary

Tenderneeds Fertility LLC is recalling the 2 X Sterile Human Home Artificial Insemination Semen Kit (SKU 143298592960). The U.S. Food and Drug Administration has classified this as a Class II recall.

The device was distributed without the proper marketing authorization required by the FDA. All affected units were distributed prior to December 9, 2019, with distribution occurring worldwide.

This recall is part of an expansion of previous enforcement actions related to unauthorized distribution of similar devices.

The recalled product

Product
2 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility and Reproductive Medicine
Hazard
  • unapproved-device

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • All lots sold prior to December 9
  • 2019.

Distribution

Distribution scope not specified by the agency.

Related recalls

Same category