The Recall Desk
HighFDA (Devices)·Z-2182-2021·Announced 2021-08-11

IntraCervical Insemination Kit Recalled for Lack of FDA Marketing Authorization

Tenderneeds Fertility LLC recalled its Deluxe IntraCervical Insemination Kit worldwide because the device was distributed without FDA marketing authorization. The device was sold 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: This is an FDA Class II device distributed without marketing authorization—a risk-of-harm product. No illnesses or injuries have been reported. Per the rubric, theoretical hazards with no reported illness are rated at most 3.

Plain-English summary

Tenderneeds Fertility LLC is recalling the Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046, worldwide. The device was distributed without proper FDA marketing authorization.

All lots of the product distributed prior to December 9, 2019, are included in this recall. Because the device was never authorized by the FDA, its safety and effectiveness have not been verified by a regulatory body.

Consumers who have this device should contact Tenderneeds Fertility LLC with questions or concerns about the recalled product. This recall is classified as FDA Class II.

The recalled product

Product
Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility
Hazard
  • missing-fda-authorization

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