FDA Device recall Z-1355-2021
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 6…
- FDA Device
- Class II
- ongoing
- Published 2021-04-14
On 2021-04-14 the FDA classified a Class II recall of At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 6… by Tenderneeds Fertility, citing device was distributed without a proper marketing authorization.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1355-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-23 |
| Published | 2021-04-14 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tenderneeds Fertility |
| Distribution | n/a |
Product
At Home Artificial Intrauterine Insemination Kit (SKU 636391205825, 636391205894, 636391205900, 636391205924, 636391205863, 636391205931, 636391205849, 636391206020, 644042787583, 636391205917, and 636391205801)
Reason
Device was distributed without a proper marketing authorization.
Identifiers
| code_info | All lots |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1355-2021%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.