Zeltiq recalls CoolCurve ZELTIQ Vacuum Applicator REF BRZ-AP1-062-000 due to increased reports of Paradoxical Hyperplasia (HP) between 2019-2021. Affected units have specific serial numbers listed in the recall notice.
Executing a voluntary discontinuation and removal of parallel plate applicators due to an increase complaint rate for adverse event Paradoxical Hyperplasia (HP) during the 2019 to 2021 timeframe.
Zeltiq is recalling its CoolCurve ZELTIQ Vacuum Applicator model REF BRZ-AP1-062-000 because of increased reports of Paradoxical Hyperplasia (HP) in users between 2019 and 2. This condition can cause abnormal tissue growth that may require medical intervention. If you own this model, you should stop using it and contact Zeltiq for a replacement.
The device has been linked to Paradoxical Hyperplasia (HP), a condition where tissue grows abnormally in response to the device's action. This can lead to complications requiring medical treatment, especially in users who have skin conditions or are undergoing cosmetic procedures.
Users of the CoolCurve ZELTIQ Vacuum Applicator REF BRZ-AP1-062-000 model from 2019 to 2021 are affected. People with skin conditions or those using the device for cosmetic procedures are at higher risk of developing Paradoxical Hyperplasia.
Check for the model number REF BRZ-AP1-062-000 on the device. The serial numbers listed in the recall notice (e.g., V06222012073001) are specific to affected units. This recall covers units sold between 2019 and 2021.
Immediately stop using the CoolCurve ZELTIQ Vacuum Applicator REF BRZ-AP1-062-000 if you own it, as it has been linked to Paradoxical Hyperplasia.
Paradoxical Hyperplasia (HP) is a condition where tissue grows abnormally in response to the device's action, which has been reported in users of this model between 2019 and 2021.
Check for the model number REF BRZ-AP1-062-000 and the specific serial numbers listed in the recall notice (e.g., V06222012073001). This recall covers units sold between 2019 and 2021.
Yes, Zeltiq will provide a replacement device if you contact them and confirm your unit is affected.
We’ve drafted a message you can send Zeltiq to request your refund or repair — edit it as you like.
Subject: Recall Z-1348-2022 — Zeltiq Zeltiq Hello, I own a Zeltiq that is covered by recall Z-1348-2022 from Zeltiq. 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.
