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Ortho8, Inc. FDA Recalls
2 recalls on file across devices, 0 of them Class I and 2 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| EVEXIA LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF(s): EVE-11/EVE-X11, Rx Only, Not SClass IIJul 9, 2021EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA cl |
| CIRCUL8 LUXE DVT PREVENTION DEVICE, Aid in the Prevention of Deep Vein Thrombosis, REF: 08-0020, Rx Prescription Only, NClass IIJul 9, 2021CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA c |