Ortho8 CIRCUL8 LUXE DVT Prevention Device Recall: Unapproved Medical Device
Ortho8 recalls CIRCUL8 LUXE DVT prevention devices sold without FDA clearance. This prescription-only device may pose risks due to lack of regulatory approval.
Recall notice
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Contact the company
What happened, in plain English
Ortho8 is recalling all CIRCUL8 LUXE DVT prevention devices sold without FDA clearance. This device is intended for prescription use to prevent deep vein thrombosis but lacks regulatory approval, which could pose health risks. Read more at govinfonow.com/recall/62220-ortho8-circul8-luxe-dvt-prevention-device-recall-unapproved-medical-device.
Source Summary by GovInfoNow · govinfonow.com/recall/62220-ortho8-circul8-luxe-dvt-prevention-device-recall-unapproved-medical-device · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2324-2021
Cite this page
“Ortho8 CIRCUL8 LUXE DVT Prevention Device Recall: Unapproved Medical Device.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62220-ortho8-circul8-luxe-dvt-prevention-device-recall-unapproved-medical-device. Based on FDA recall #Z-2324-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2324-2021%22&limit=1).
Why it’s dangerous
The device was marketed without FDA clearance, meaning it hasn't undergone the required safety and effectiveness testing. This could lead to potential health risks if used without proper regulatory oversight.
Who’s affected
Prescription patients using the CIRCUL8 LUXE DVT prevention device are affected. Those with medical conditions requiring blood clot prevention may be at higher risk.
How to tell if you have this one
Check for the CIRCUL8 LUXE DVT prevention device with the product reference number REF: 08-0020. All lots of this device are included in the recall.
- Brand
Ortho8- Category
Medical device
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Ongoing- Distribution
US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.
| Recall number | Product, codes & lots |
|---|---|
| Z-2324-2021 | CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,; All Lots |
| 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; All Lots |
What to do — step by step
Check Device Details
Identify the product by checking for the reference number REF: 08-0020 on the device packaging.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 27 states.
FDA distribution: “US Nationwide distribution in the states of Al, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MA, MI, MO, NC, NV, NJ, NY, OK, PA, SC, TN, TX, UT, VA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, Nevada, New Jersey, New York, North Carolina, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, Virginia.
Recall timeline
FDA published this recall 47 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #Z-2324-2021 (July 9, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2324-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.