The Recall Desk
HighFDA (Devices)·Z-2180-2021·Announced 2021-08-11

TenderNeeds IUI Fertility Kits Distributed Without FDA Marketing Authorization

TenderNeeds Fertility PRO IUI home insemination kits 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: FDA Class II devices distributed without proper marketing authorization represent a regulatory violation with potential for harm. However, the source text contains no reports of illnesses, injuries, or deaths, placing this recall in the 'risk-of-harm' category where injury has not yet been reported.

Plain-English summary

TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits (SKU 133166055771) are subject to a recall. The kits were manufactured by Tenderneeds Fertility LLC and distributed worldwide.

The devices were distributed without the proper FDA marketing authorization required before such products are sold to consumers. This recall represents an expansion of previous FDA enforcement actions (RES 87581, Z-1355-2021 through Z-1364-2021) related to unauthorized device distribution.

All lots of these kits distributed prior to December 9, 2019, are included in this recall.

The recalled product

Product
TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility Device
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