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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II medical device without reported illnesses or injuries. The hazard is regulatory non-compliance (marketing without FDA clearance), making this a risk-of-harm situation with no reported injury, which per the rubric scores as High (3).
Plain-English summary
The CIRCUL8 LUXE DVT Prevention Device (REF: 08-0020), manufactured by Ortho8 Inc., is being recalled. This device is intended to aid in the prevention of deep vein thrombosis (DVT).
Reason for Recall: The device is marketed without FDA clearance. In the United States, medical devices must receive FDA clearance before being marketed to patients to ensure they are safe and effective.
Distribution: The device has been distributed nationwide across 29 states: 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.
Recommendations: Patients who have received this device should consult their healthcare provider regarding this recall and to discuss available alternatives for DVT prevention.
The recalled product
- 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,
- Manufacturer
- Ortho8, Inc.
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
Part of a larger recall action
This product is one of 2 recalled by Ortho8, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Ortho8, Inc.
See all →- HighEvexia Luxe DVT Prevention Device Recalled for Marketing Without FDA Clearance
FDA (Devices) · 2021-08-25
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