Skip to content
Get alerts
GovInfoNow
Lower risk Medical device recall · FDA · Published December 23, 2020

Tenderneeds Fertility Deluxe ICI Kit Recall: Unapproved Marketing

Tenderneeds Fertility recalls Deluxe IntraCervical Insemination Kits sold before Dec 9, 2019 due to lack of proper marketing authorization. No action needed as the product is unapproved but not dangerous.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #Z-2182-2021Medical deviceTenderneeds Fertility ›
Take action

Contact the company

Recalling firmTenderneeds Fertility LLC10162 Bradford Rd · Greenville, IN 47124-9227
✎ GovInfoNow plain-language explainer

Tenderneeds Fertility is recalling Deluxe IntraCervical Insemination (ICI) Kits sold before December 9, 2019 because they were distributed without proper marketing authorization. This does not pose a safety risk to users. Read more at govinfonow.com/recall/63597-tenderneeds-fertility-deluxe-ici-kit-recall-unapproved-marketing.

Source Summary by GovInfoNow · govinfonow.com/recall/63597-tenderneeds-fertility-deluxe-ici-kit-recall-unapproved-marketing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2182-2021

Cite this page

“Tenderneeds Fertility Deluxe ICI Kit Recall: Unapproved Marketing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63597-tenderneeds-fertility-deluxe-ici-kit-recall-unapproved-marketing. Based on FDA recall #Z-2182-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2182-2021%22&limit=1).

The FDA announced on December 23, 2020, that Tenderneeds Fertility LLC is recalling the Deluxe IntraCervical Insemination (ICI) Kit because it was distributed without proper marketing authorization. This action expands upon previous recalls identified in RES 87581.

How to tell if you have it

  • Brand: Tenderneeds Fertility
  • Product: Deluxe IntraCervical Insemination (ICI) Kit (3)
  • SKU: 382903096046
  • Lots sold prior to December 9, 2019

The hazard

The device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Context

GovInfoNow's records show Tenderneeds Fertility LLC has one other recall on record since December 23, 2020, specifically the Tenderneeds Pro Series Fertility Device Recall for missing marketing authorization. Other recent recalls of similar products include Female Fertility Test Recall (November 3, 2025), GET TESTED Ovulation Test Recall (November 3, 2025), and Medline Convenience Kits Recall (January 7, 2026).

How to tell if you have this one

Check for the SKU 382903096046 on the kit. Products sold before December 9, 2019 are affected.

  • Brand
    Tenderneeds Fertility
  • Category
    Medical device
FDA recall event · 9 products

All 9 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Ongoing
  • Distribution
    Worldwide distribution.
Recall numberProduct, codes & lots
Z-2175-2021Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001; All lots sold prior to December 9, 2019.
Z-2176-2021Home Artificial Insemination Kit Human IUI ICI Pregnancy & Ovulation Tests, SKU midiuikt; All lots sold prior to December 9, 2019.
Z-2177-2021Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887; All lots sold prior to December 9, 2019.
Z-2178-2021Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW; All lots sold prior to December 9, 2019.
Z-2179-20212 X Sterile Human Home Artificial Insemination Semen Kit (Human), SKU 143298592960; All lots sold prior to December 9, 2019.
Z-2180-2021TenderNeeds Fertility PRO IUI Human Artificial Home Insemination Kits, SKU 133166055771; All lots sold prior to December 9, 2019.
Z-2181-2021Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856; All lots sold prior to December 9, 2019.
Z-2182-2021Deluxe IntraCervical Insemination (ICI) Kit (3), SKU 382903096046; All lots sold prior to December 9, 2019.
Z-2183-20212 Complete ICI Human At Home Donor Artificial Insemination Kits Tenderneeds, SKU unknown; All lots sold prior to December 9, 2019.
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Verify the SKU number and sale date to confirm if the kit is affected.

How this recall unfolded

Recall timeline

FDA published this recall 8 months after the firm started it.

1. Firm started the recall: Dec 23, 202012. FDA classified it Class II: Aug 2, 202123. Published in FDA’s Enforcement Report: Aug 11, 2021320202021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Safeguard US Recalls Battle Bandages and IFAK Kits Due to Infection Risk
Safeguard US Operating LLCMiniMed Flex Insulin Pump Recall: Inaccurate Delivery Risk
Medtronic MiniMed, Inc.Medline Bariatric Rollator Recall: Detaching Wheels Risk
Medline Industries, LPCooperVision Pearle Vision 1 Day Contact Lenses: Incorrect Power Risk
CooperVision, Inc.Tandem t:slim App Recall: Pairing Issue With Abbott Sensors
Tandem Diabetes Care, Inc.

Latest medical device recalls

BMC Medical Co., Ltd. recalls BMC/REACTHEALTH Luna G3 APAP REF LG 3600
BMC Medical Co., Ltd. · July 15, 2026Medtronic MiniMed, Inc. recalls MiniMed 670G Insulin Pump, Model: MMT-1781, MMT-1782;
Medtr: MiniMed · July 13, 2026INTEGRATED MEDCRAFT LLC recalls Kingfisher Compact Individual First Aid Kit. REF Number: 76656. Containing the affected One-piece Guedel airway
Medcraft · July 7, 2026Pride Mobility Products Corp. recalls Brand Name: Quantum Rehab Product Name: R-TRAK Model/Catalog Number: R-TRAK Software Version: 2.0.11, new version:
Quantum Rehab · June 25, 2026ResMed Ltd. recalls Resmed Astral 100/150 Resmed Astral 100/50 is a ventilator system that provides continuous or intermittent ventilatory
ResMed · June 25, 2026Therabody, Inc recalls Charger for the Therabody Theragun, G4 PRO massage device, and products which include the 4th Generation Theragun PRO
Therabody · June 23, 2026

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2182-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2182-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA