Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
CIRCUL8 LUXE DVT PREVENTION DEVICE Recalled by Ortho8, Inc. Due to CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Ortho8, Inc. directly.
Affected Products
CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, Not Sterile IP22, Latex Free,
Quantity: N/A
Why Was This Recalled?
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Ortho8, Inc.
Ortho8, Inc. has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report