The Recall Desk
HighFDA (Devices)·Z-2175-2021·Announced 2021-08-11

Fertility IUI Device Recalled for Missing FDA Marketing Authorization

Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum due to distribution without FDA marketing authorization. All units sold worldwide prior to 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 classified this as a Class II device, indicating reasonable probability of adverse health consequences if used. Although no illnesses or injuries have been reported, the device was distributed without FDA marketing authorization, making it a risk-of-harm product that has not undergone proper safety and effectiveness review.

Plain-English summary

Tenderneeds Fertility LLC is recalling the Flex IUI Set with LED Lighted Speculum and Test kit (SKU fls1001), a medical device designed for intrauterine insemination procedures. All units distributed worldwide prior to December 9, 2019 are included in this recall.

The device was distributed without obtaining the required FDA marketing authorization. Medical devices must receive FDA clearance or approval before being legally marketed in the United States. This is a Class II recall, indicating the FDA determined that reasonable probability exists that use of the device could cause adverse health consequences.

This recall is an expansion of related enforcement actions (RES 87581 and recalls Z-1355-2021 through Z-1364-2021). No illnesses or injuries have been reported. Patients or healthcare providers who obtained this device should contact Tenderneeds Fertility LLC or the FDA for guidance on appropriate follow-up actions.

The recalled product

Product
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Manufacturer
Tenderneeds Fertility LLC
Category
Medical Device — Fertility / Reproductive
Hazard
  • unauthorized-distribution
  • lack-of-fda-clearance

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