The Recall Desk

Manufacturer

Zeltiq Aesthetics, Inc

6 recalls in our database name Zeltiq Aesthetics, Inc as the manufacturing or recalling firm.

What the numbers show

Total
6
Critical
0
Severe
1
Most recent
2022-07-20

Of the 6 recalls from Zeltiq Aesthetics, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (17%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–6 of 6

  • SevereFDA (Devices)·Z-1349-2022·2022-07-20

    CoolCurve+ Vacuum Applicator Recalled for Increased Paradoxical Hyperplasia Reports

    Zeltiq Aesthetics is voluntarily recalling CoolCurve+ ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia during 2019–2021, an adverse event involving abnormal fat growth at treatment sites.

    Product
    CoolCurve+ ZELTIQ Vacuum Applicator REF BRZ-AP1-064-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1347-2022·2022-07-20

    CoolCore ZELTIQ Vacuum Applicator Voluntarily Recalled Due to Paradoxical Hyperplasia

    Zeltiq Aesthetics is voluntarily recalling CoolCore ZELTIQ Vacuum Applicators due to increased reports of Paradoxical Hyperplasia, an adverse effect causing unwanted fat tissue growth. The recall affects 3,054 units distributed across the U.S. and internationally.

    Product
    CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-1346-2022·2022-07-20

    CoolMax ZELTIQ Vacuum Applicator recalled for paradoxical hyperplasia complaints

    Zeltiq Aesthetics is voluntarily discontinuing 2,945 CoolMax ZELTIQ Vacuum Applicators due to an increase in paradoxical hyperplasia complaints between 2019 and 2021, an adverse event causing unwanted tissue growth instead of intended fat reduction.

    Product
    CoolMax ZELTIQ Vacuum Applicator REF BRZ-AP1-080-000
    Category
    Medical Device
    Distribution
    52 states
  • HighFDA (Devices)·Z-2383-2021·2021-09-08

    CoolSculpting Elite System Software Error May Misreport Thermal Events

    The CoolSculpting Elite System may incorrectly report or fail to report thermal events during treatment, potentially causing unnecessary re-treatment or continued use without awareness of a malfunction.

    Product
    CoolSculpting Elite System The CoolSculpting System SW release 2.0, SW release 3.0, SW release 3.0.1, SW release 3.0.2
    Category
    Medical Device
    Distribution
    44 states

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zeltiq Aesthetics

a public company based in Pleasanton, California

Country
United States
Founded
2005

Official website

Source: Wikidata (Q16968424), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.