FDA Medical Device Recalls (openFDA)
Tenderneeds Fertility LLC: Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Recall number
- Z-2181-2021
- Recalling firm
- Tenderneeds Fertility LLC
- Product
- Deluxe At-Home Human Artificial Intracervical (ICI) Insemination Kit with Pregnancy & Ovulation Tests, SKU 636391205856
- Status
- Open, Classified
- Initiated
- 2020-12-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
- 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
- Unknown
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- All lots sold prior to December 9, 2019.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- MQF
- Firm FEI
- 3012228225
- Firm city
- Greenville
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28