The Recall Desk
HighFDA (Devices)·Z-2176-2021·Announced 2021-08-11

Home Artificial Insemination Kit Recalled for Lack of Marketing Authorization

Tenderneeds Fertility LLC is recalling home artificial insemination kits that were distributed without proper FDA authorization. The device was sold worldwide prior to December 9, 2019.

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: FDA Class II medical device distributed without proper marketing authorization. While no illnesses or injuries have been reported, an unapproved medical device constitutes a risk-of-harm product. The rubric classifies risk-of-harm products without reported injury as High severity.

Plain-English summary

The recall covers the Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests (SKU midiuikt), manufactured by Tenderneeds Fertility LLC. This product was distributed worldwide without proper FDA marketing authorization.

The FDA requires medical devices to obtain appropriate marketing authorization before distribution. This kit was sold without meeting this requirement. All lots distributed prior to December 9, 2019 are affected by this recall.

If you have purchased this product, stop using it and contact Tenderneeds Fertility LLC for further instructions.

The recalled product

Product
Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility / Reproductive Health
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