Unrated Medical device recall · FDA · Published December 23, 2020

Tenderneeds Fertility At Home Insemination Device Recall: Unapproved Marketing

Tenderneeds Fertility LLC recalls all At Home Semi-Flex/Rigid Insemination Devices (SKU 644042787903) due to distribution without proper marketing authorization. No remedy specified in official notice.

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

🇺🇸 FDA recall #Z-1356-2021Medical device Tenderneeds Fertility ›

Recall notice

Device was distributed without a proper marketing authorization.

Take action

Contact the company

Recalling firmTenderneeds Fertility LLC10162 Bradford Rd · Greenville, IN 47124-9227

✎ GovInfoNow plain-language explainer

Tenderneeds Fertility LLC is recalling all At Home Semi-Flex/Rigid Insemination Devices (SKU 644042787903) because they were distributed without proper marketing authorization. This recall does not involve a safety hazard but addresses regulatory compliance issues. Read more at govinfonow.com/recall/63598-tenderneeds-fertility-at-home-insemination-device-recall-unapproved-marketing.

Source Summary by GovInfoNow · govinfonow.com/recall/63598-tenderneeds-fertility-at-home-insemination-device-recall-unapproved-marketing · Updated August 19, 2026 · FDA enforcement record: FDA #Z-1356-2021

Cite this page

“Tenderneeds Fertility At Home Insemination Device Recall: Unapproved Marketing.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/63598-tenderneeds-fertility-at-home-insemination-device-recall-unapproved-marketing. Based on FDA recall #Z-1356-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1356-2021%22&limit=1).

The FDA announced on Dec. 23, 2020, that Tenderneeds Fertility LLC is recalling its At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903) because it was distributed without proper marketing authorization. This voluntary Class II recall affects all lots of the device.

How to tell if you have it

Brand: Tenderneeds Fertility
Product: At Home Semi-Flex/Rigid Insemination Device
SKU: 644042787903
Lots: All

The hazard

The device was distributed without a proper marketing authorization, according to the FDA.

Context

GovInfoNow's records show that Tenderneeds Fertility LLC has one other recall on record since Dec. 23, 2020, which involved missing marketing authorization for an At Home Insemination Kit. Other recent recalls of similar products include Female Fertility Test Recall (Nov. 3, 2025), Changchun Wancheng Male Fertility Sperm Test Cassette (Nov. 22, 2025), and GET TESTED Sperm Test Recall (Nov. 3, 2025).

How to tell if you have this one

Check for the SKU 644042787903 on the device packaging. All lots of this product are affected by the recall.

Brand
Tenderneeds Fertility
Category
Medical device

FDA recall event · 10 products

All 10 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
World-wide distribution.

Recall number	Product, codes & lots
Z-1355-2021	At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801); All lots
Z-1356-2021	At Home Semi-Flex/Rigid Insemination Device (SKU 644042787903); All lots
Z-1357-2021	At Home Artificial Intrauterine Insemination Flex Set (SKU 636391205870); All lots
Z-1358-2021	Deluxe At Home Pro Series Insemination Kit (SKU 644042787958); All lots
Z-1359-2021	Deluxe At Home Artificial Insemination Kit (SKU 636391205832); All lots
Z-1360-2021	Premium At Home Pro Series Insemination Kit (SKU 644042787927); All lots
Z-1361-2021	Professional Artificial Intrauterine Insemination Kit (SKU 636391205986); All lots
Z-1362-2021	Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013); All lots
Z-1363-2021	Pro Series Fertility Device (SKU 644042788139); All lots
Z-1364-2021	Professional At Home Artificial Intrauterine Insemination Set (SKU 644042787811); All lots

Based on the official FDA remedy

What to do — step by step

Check Device Details
Identify the SKU 644042787903 on the product packaging to confirm if it is affected.

How this recall unfolded

Recall timeline

FDA published this recall 4 months after the firm started it.

Dec 23, 2020Firm started the recall
Apr 6, 2021FDA classified it Class II
Apr 14, 2021Published in FDA’s Enforcement Report

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

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Link to this recall

<a href="https://govinfonow.com/recall/63598-tenderneeds-fertility-at-home-insemination-device-recall-unapproved-marketing">Tenderneeds Fertility At Home Insemination Device Recall: Unapproved Marketing (GovInfoNow)</a>

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-1356-2021 (December 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1356-2021 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.