The Recall Desk
ModerateFDA (Devices)·Z-2177-2021·Announced 2021-08-11

FDA Recalls IUI Kit and Metal Speculum for Lacking Marketing Authorization

Tenderneeds Fertility LLC is recalling the Premium Human IUI Kit and Metal Speculum because it was distributed without required FDA marketing authorization. All products sold before December 9, 2019 are affected.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for regulatory non-compliance: the device was distributed without the required marketing authorization. No adverse events or patient injuries are reported in the source material.

Plain-English summary

Tenderneeds Fertility LLC is recalling the Premium Human Artificial Intrauterine Insemination (IUI) Kit and Metal Speculum, SKU 636391205887. The device was distributed without the required FDA marketing authorization.

The recall affects all lots sold prior to December 9, 2019, and the products were distributed worldwide. This is a Class II recall and represents an expansion of previous FDA recall actions (RES 87581, Z-1355-2021 through Z-1364-2021).

The recalled product

Product
Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility / Reproductive
Hazard
  • regulatory-non-compliance
  • unauthorized-distribution

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