Ortho8 recalls CIRCUL8 LUXE DVT prevention devices sold without FDA clearance. This prescription-only device may pose risks due to lack of regulatory approval.
CIRCUL8 LUXE DVT PREVENTION DEVICE is marketed without FDA clearance
Ortho8 is recalling all CIRCUL8 LUXE DVT prevention devices sold without FDA clearance. This device is intended for prescription use to prevent deep vein thrombosis but lacks regulatory approval, which could pose health risks.
The device was marketed without FDA clearance, meaning it hasn't undergone the required safety and effectiveness testing. This could lead to potential health risks if used without proper regulatory oversight.
Prescription patients using the CIRCUL8 LUXE DVT prevention device are affected. Those with medical conditions requiring blood clot prevention may be at higher risk.
Check for the CIRCUL8 LUXE DVT prevention device with the product reference number REF: 08-0020. All lots of this device are included in the recall.
Identify the product by checking for the reference number REF: 08-0020 on the device packaging.
The recall indicates the device was marketed without FDA clearance, so safety has not been confirmed through regulatory approval.
The recall does not specify a stop-use instruction; however, the device lacks FDA clearance, which may pose health risks.
The recall record does not mention any remedy or replacement options.
We’ve drafted a message you can send Ortho8 to request your refund or repair — edit it as you like.
Subject: Recall Z-2324-2021 — Ortho8 Ortho8 Hello, I own a Ortho8 that is covered by recall Z-2324-2021 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.
