CLASS II ONGOING Device recall · Reported 11 Aug 2021 · FDA Enforcement Report

Premium Human Artificial Intrauterine Insemination recalled

Tenderneeds Fertility is recalling Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum. 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 sold prior to December 9, 2019.

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-2177-2021
FDA event ID: 88225
Recalling firm: Tenderneeds Fertility, Greenville, IN
Classification: Class II
Status: Ongoing
Recall initiated: 23 Dec 2020
FDA classified: 2 Aug 2021
Reported: 11 Aug 2021
Type: Voluntary: Firm initiated
Customers notified by: Other
Reason category: Foreign Material
Device type: Other Medical Devices

Timeline

23 Dec 2020	Recall initiated by company
2 Aug 2021	Classified by FDA	+222 days
11 Aug 2021	Published in enforcement report	+9 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. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Premium Human Artificial Intrauterine Insemination (IUI) Kit & Metal Speculum, SKU 636391205887

Where it was distributed

Worldwide distribution.

Questions about this recall

Why was it recalled?

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

Which lots are affected?

All lots sold prior to December 9, 2019.

Where was it sold?

Worldwide 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

8 other products · FDA event 88225

This product is part of a recall event; the main page for the event is Deluxe IntraCervical Insemination (ICI) Kit recalled.

Reported	Class	Recall	Company	Reason	Where
11 Aug 2021	CLASS II	Deluxe IntraCervical Insemination (ICI) Kit recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	Flex IUI Set with LED Lighted Speculum and Test kit recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	Deluxe At-Home Human Artificial Intracervical recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	Home Artificial Insemination Kit Human IUI ICI Pregnancy recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	2 Complete ICI Human At Home Donor Artificial Insemination recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	PRO IUI Human Artificial Home Insemination Kits recalled	Tenderneeds Fertility	Other	IN
11 Aug 2021	CLASS II	2 X Sterile Human Home Artificial Insemination Semen Kit (Human) recalled	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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