The Recall Desk
HighFDA (Devices)·Z-2183-2021·Announced 2021-08-11

Artificial insemination kits recalled for lack of FDA authorization

Tenderneeds Fertility LLC is recalling artificial insemination kits that were distributed without proper FDA marketing authorization. All lots sold before December 9, 2019 are affected.

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 an FDA Class II recall of a medical device distributed without proper marketing authorization. Although no illnesses or injuries have been reported, the lack of FDA authorization means the device's safety and effectiveness have not been verified, representing an unreviewed risk to consumers.

Plain-English summary

Tenderneeds Fertility LLC is recalling the 2 Complete ICI Human At Home Donor Artificial Insemination Kits. The kits were distributed without proper FDA marketing authorization.

The FDA did not review or approve this device before it was sold to consumers. The manufacturer did not obtain the required regulatory clearance or authorization from the FDA before marketing the product.

All lots sold prior to December 9, 2019 are included in this recall. The kits were distributed worldwide.

Consumers who obtained this device should stop using it. Contact Tenderneeds Fertility LLC or consult with a healthcare provider for guidance on returning or disposing of the product.

The recalled product

Product
2 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — At-Home Fertility Kit
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