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.
EVEXIA LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Ortho8 is recalling its EVEXIA LUXE DVT prevention device (model EVE-11/EVE-X11) because it was sold without FDA approval. This device is intended for patients with deep vein thrombosis but lacks regulatory clearance, which could lead to safety concerns.
The device was marketed without FDA clearance, meaning it hasn't undergone the necessary safety and efficacy testing. This could result in improper function or harm to users who rely on it for medical treatment.
Patients prescribed this device for deep vein thrombosis prevention are likely affected. Those using the device without medical supervision are at higher risk.
Check for the model numbers EVE-11 or EVE-X11 on the device. The product is sold under the brand Ortho8 and is intended for prescription use only.
Look for model numbers EVE-11 or EVE-X11 on the device label.
The recall states the device was marketed without FDA clearance, but the official notice does not specify if it is safe to use.
The recall record does not provide specific action steps for affected users.
The recall indicates the device was marketed without FDA clearance, so it is not approved.
We’ve drafted a message you can send Ortho8 to request your refund or repair — edit it as you like.
Subject: Recall Z-2325-2021 — Ortho8 Ortho8 Hello, I own a Ortho8 that is covered by recall Z-2325-2021 from Ortho8. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
