The Recall Desk
HighFDA (Devices)·Z-2178-2021·Announced 2021-08-11

Medical Device Recall: Unauthorized Fertility Insemination Kit

All lots of the Ultimate Fertility At Home Insemination Kit sold before December 9, 2019 are recalled. The device was distributed without 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: FDA Class II device distributed without proper marketing authorization represents a risk of harm, as the device's safety and effectiveness were not verified by the FDA. No illnesses or injuries have been reported.

Plain-English summary

Tenderneeds Fertility LLC is recalling the Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium (SKU ULTFKSW). The recall affects all lots sold prior to December 9, 2019. The product was distributed worldwide.

The device was recalled because it was distributed without proper FDA marketing authorization. Devices require FDA approval before they can be marketed and sold to ensure their safety and effectiveness.

The recalled product

Product
Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility / Reproductive Health
Hazard
  • unapproved

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