RegWardenFDA facility compliance records
Facility

ZELTIQ AESTHETICS INC.

2 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2016: 1 inspections; 2021: 1 recalls; 2022: 1 recalls12016201720182019202012021120222023202420252026
  • Recalls (2)
  • Inspections (1)

Devices registered here (1)

  • Dermal Cooling Pack/Vacuum/Massager
    Product code OOK (opens in a new tab) · Class II · General, Plastic Surgery · 21 CFR 878.4340

Recalls & enforcement

  • Class IIOngoing2022-06-09
    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.
  • Class IITerminated2021-07-05
    An incorrect error messaging system that could potentially lead to: 1) Reporting a thermal event error causing a user to re-treating the affected anatomic area within 24 hours, 2) Not reporting a thermal event or any other error codes causing a user to continue treating without b…

FDA inspections (1)

  • NAI2016-03-11
    No Action Indicated · Compliance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ZELTIQ AESTHETICS INC. (FEI 3009974688) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3009974688-zeltiq-aesthetics-inc/

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