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.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a Class II medical device marketed without FDA clearance. Although no injuries or illnesses have been reported, the device is intended to prevent deep vein thrombosis, a serious medical condition, making this a risk-of-harm product where injury has not yet been reported.
Plain-English summary
Ortho8, Inc. is recalling the Evexia Luxe DVT Prevention Device (model references EVE-11/EVE-X11) across the United States. The device was marketed and distributed without the required FDA clearance.
The Evexia Luxe is intended to aid in the prevention of deep vein thrombosis, a serious blood clotting condition. According to the FDA, the device was placed on the market without obtaining the necessary regulatory approval.
The affected product has been distributed nationwide to healthcare facilities in Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maryland, Massachusetts, Michigan, Missouri, North Carolina, Nevada, New Jersey, New York, Oklahoma, Pennsylvania, South Carolina, Tennessee, Texas, Utah, and Virginia. All lots of the device are affected.
If you have this device or are involved in its use, contact your healthcare provider or Ortho8, Inc. for guidance on proper handling and potential alternatives.
The recalled product
- Product
- EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not Sterile
- Manufacturer
- Ortho8, Inc.
- Category
- Medical Device
- Hazard
- regulatory-violation
- uncleared-medical-device
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All Lots
Distribution
Distributed nationwide across the United States.
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