The Recall Desk

FDA (Devices) recall action 88308

Ortho8, Inc. recalled 2 products on 2021-08-25

The FDA (Devices) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-08-25
Critical
0
Units
—

Why these products were recalled

CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance

The agency’s own wording, quoted from the enforcement report.

States named across these recalls

1–2 of 2

  • HighFDA (Devices)··2021-08-25

    CIRCUL8 LUXE DVT Prevention Device Marketed Without FDA Clearance

    The CIRCUL8 LUXE DVT Prevention Device is being recalled because it was marketed without FDA clearance. The device is intended to aid in the prevention of deep vein thrombosis.

    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,
    Category
    Distribution
    28 states
  • HighFDA (Devices)··2021-08-25

    Evexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance

    Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device because it was marketed without required FDA clearance. The device is intended to prevent deep vein thrombosis.

    Product
    EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
    Category
    Distribution
    28 states