FDA Device recall Z-2175-2021
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
- FDA Device
- Class II
- ongoing
- Published 2021-08-11
On 2021-08-11 the FDA classified a Class II recall of Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001 by Tenderneeds Fertility, citing device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2175-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2020-12-23 |
| Published | 2021-08-11 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Tenderneeds Fertility |
| Distribution | n/a |
Product
Flex IUI Set with LED Lighted Speculum and Test kit, SKU fls1001
Reason
Device was distributed without a proper marketing authorization. This event is an expansion of RES 87581, Z-1355-2021 thru Z-1364-2021.
Identifiers
| code_info | All lots sold prior to December 9, 2019. |
|---|
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-2175-2021%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.