The Recall Desk

Hazard

Paradoxical Hyperplasia recalls

5 recalls in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
5
Critical
0
Severe
1
Most recent
2022-07-20

Of the 5 paradoxical hyperplasia recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (20%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all paradoxical hyperplasia recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–5 of 5

  • 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-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-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