FDA Device recall Z-2325-2021
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
- FDA Device
- Class II
- ongoing
- Published 2021-08-25
On 2021-08-25 the FDA classified a Class II recall of EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile by Ortho8, citing EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2325-2021 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2021-07-09 |
| Published | 2021-08-25 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Ortho8 |
| Distribution | US |
Product
EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
Reason
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
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-2325-2021%22
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