Every recall we track for Ortho8, Inc. — 2 in all — plus the complaints and injury reports the public filed about them.
Ortho8 recalls its EVEXIA LUXE DVT prevention device (EVE-11/EVE-X11) as it was marketed without FDA clearance. This unapproved device may pose risks for patients with deep vein thrombosis.
Ortho8 recalls CIRCUL8 LUXE DVT prevention devices sold without FDA clearance. This prescription-only device may pose risks due to lack of regulatory approval.
