Z-2178-2021Class II

Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW

Name: Z-2178-2021 Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Creator: Tenderneeds Fertility LLC
Published: 2020-12-23
License: https://open.fda.gov/license/

Tenderneeds Fertility LLC / initiated 2020-12-23 / Open, Classified

FDA source

Tenderneeds Fertility LLC began a recall of Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW on 2020-12-23. FDA classified it as Class II and gives the reason as "Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2178-2021
Classification: Class II
Status: Open, Classified
Initiated: 2020-12-23
Posted: 2021-08-02
Recalling firm: Tenderneeds Fertility LLC
Product: Ultimate Fertility At Home Insemination Kit with Sperm Wash Medium, SKU ULTFKSW
Product code: MQF Catheter, Assisted Reproduction
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.
FDA root cause: No Marketing Application
Action: On December 23, 2020, the firm published a recall notification on its website at the following URL: https://tenderneedsfertility.com/recalls. The notification notified customers that all IUI and ICI kits sold for human use were being recalled. Customers were instructed to destroy these products, including leftover portions, immediately. The firm did not ask customers to return the product. This event was previously recorded under RES 87851. On June 9, 2021, firm updated recall communication on website to include more information about the recall. All IUI and ICI kits sold for human use by the firm prior to December 9, 2019 are subject to the recall. Some of the products listed in the notice were not previously captured by FDA's summary. This event (RES 88225) was created to document these additional products.
Quantity in commerce: Unknown
Distribution: Worldwide distribution.
Product codes and lots: All lots sold prior to December 9, 2019.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2178-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2175-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2176-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2177-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2178-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2179-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2180-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2181-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2182-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02
Z-2183-2021	Class II	Ongoing	Voluntary: Firm initiated	2021-08-11	2021-08-02

Product code MQF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)