Zeltiq recalls CoolFit ZELTIQ Vacuum Applicators with specific serial numbers due to increased reports of Paradoxical Hyperplasia (HP) from 2019-2021. Affected units may cause skin growths in the treatment area.
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 specific CoolFit ZELTIQ Vacuum Applicators (serial numbers listed) because they have been linked to Paradoxical Hyperplasia (HP), a skin growth condition, in users from 2019 to 2021. This risk is not immediate but has been reported over time.
The device has been associated with Paradoxical Hyperplasia (HP), a skin growth condition, in users during the 2019-2021 timeframe. This occurs due to the device's design causing an unusual skin response in some individuals.
Users of the CoolFit ZELTIQ Vacuum Applicator with the listed serial numbers (from 2019-2021) are affected. This risk is not for all users but those who have experienced the reported adverse events.
Check if your CoolFit ZELTIQ Vacuum Applicator has a serial number starting with 'V066' followed by 12-14 digits (e.g., V0662016146015). The recall covers specific units from 2019-2021.
Look for the serial number on your device, which starts with 'V066' followed by 12-14 digits (e.g., V0662016146015).
If your device is listed in the recall, contact Zeltiq directly for instructions on how to return it.
Paradoxical Hyperplasia (HP) is a skin growth condition that has been reported in users of this device during the 2019-2021 timeframe.
No, but if your device has a serial number listed in the recall, you should contact Zeltiq to return it.
Check the serial number on your device; it starts with 'V066' followed by 12-14 digits (e.g., V0662016146015).
We’ve drafted a message you can send Zeltiq to request your refund or repair — edit it as you like.
Subject: Recall Z-1350-2022 — Zeltiq Zeltiq Hello, I own a Zeltiq that is covered by recall Z-1350-2022 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.
