CIRCUL8 LUXE DVT PREVENTION DEVICE — Class II medical device recall Z-2324-2021
Ongoing recall by Ortho8, Inc., reported 2021-08-25, distributed nationwide. CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
| Recall number | Z-2324-2021 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho8, Inc., Rocklin, CA, United States |
| Recall initiated | 2021-07-09 |
| Classified | 2021-08-19 |
| Reported by FDA | 2021-08-25 |
| Distributed | Nationwide (US) |
| Lot numbers | CIRCUL8 |
| Model numbers | 08-0020 |
Product
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Reason for recall
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-2324-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.