CLASS II ONGOING Device recall · Reported 14 Apr 2021 · FDA Enforcement Report

Professional Clinical Artificial Intrauterine Insemination Kit recalled

Tenderneeds Fertility is recalling Professional Clinical Artificial Intrauterine Insemination Kit (. The recall was initiated on 23 Dec 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalledUnknown

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1362-2021
FDA event ID: 87581
Recalling firm: Tenderneeds Fertility, Greenville, IN
Classification: Class II
Status: Ongoing
Recall initiated: 23 Dec 2020
FDA classified: 6 Apr 2021
Reported: 14 Apr 2021
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

23 Dec 2020	Recall initiated by company
6 Apr 2021	Classified by FDA	+104 days
14 Apr 2021	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Device was distributed without a proper marketing authorization.

Product as listed by the FDA

Professional Clinical Artificial Intrauterine Insemination Kit (SKU 636391205962, 636391206013)

Where it was distributed

World-wide distribution.

Questions about this recall

Why was it recalled?

Device was distributed without a proper marketing authorization.

Which lots are affected?

All lots

Where was it sold?

World-wide distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

9 other products · FDA event 87581

This product is part of a recall event; the main page for the event is At Home Semi-Flex/Rigid Insemination Device recalled.

Reported	Class	Recall	Company	Reason	Where
14 Apr 2021	CLASS II	At Home Semi-Flex/Rigid Insemination Device recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Deluxe At Home Pro Series Insemination Kit recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Premium At Home Pro Series Insemination Kit recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	At Home Artificial Intrauterine Insemination Kit recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	At Home Artificial Intrauterine Insemination Flex Set recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Professional At Home Artificial Intrauterine Insemination Set recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Deluxe At Home Artificial Insemination Kit recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Professional Artificial Intrauterine Insemination Kit recalled	Tenderneeds Fertility	Other	IN
14 Apr 2021	CLASS II	Pro Series Fertility Device recalled by Tenderneeds Fertility	Tenderneeds Fertility	Other	IN

More recalls from Tenderneeds Fertility

All 19

Reported	Class	Recall	Company	Reason	Where
11 Aug 2021Device	CLASS II	2 X Sterile Human Home Artificial Insemination Semen Kit (Human) recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021Device	CLASS II	PRO IUI Human Artificial Home Insemination Kits recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021Device	CLASS II	2 Complete ICI Human At Home Donor Artificial Insemination recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021Device	CLASS II	Home Artificial Insemination Kit Human IUI ICI Pregnancy recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021Device	CLASS II	Deluxe At-Home Human Artificial Intracervical recalled	Tenderneeds Fertility	Other	IN

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