FDA Medical Device Recalls (openFDA)
Tenderneeds Fertility LLC: Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
- Recall number
- Z-1358-2021
- Recalling firm
- Tenderneeds Fertility LLC
- Product
- Deluxe At Home Pro Series Insemination Kit (SKU 644042787958)
- Status
- Open, Classified
- Initiated
- 2020-12-23
- Posted
- not on file
- Terminated
- not on file
- Reason
- Device was distributed without a proper marketing authorization.
- 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.
- Quantity
- Unknown
- Distribution
- World-wide distribution.
- Lot, serial or model codes
- All lots
- 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