CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000 — FDA record Z-1347-2022

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Jun 9, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
CoolCore ZELTIQ Vacuum Applicator REF BRZ-AP1-063-000
Reason
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.
Classification
Class II
Recalling firm
Zeltiq Aesthetics, Inc
Quantity
3,054 units
Agency-reported status
Ongoing
Source record identifier
Z-1347-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityCoolCore REF: BRZ-AP1-063-000 BRZ-AP1-063-000_F BRZ-AP1-063-000_K BRZ-AP1-063-000_R UDI-DI: 00816417020179 Serial Numbers: V0632018051020 V0632018051019 V0632018051018 V0632018051013 V0632018051009 V0632018051008 V0632018044020 V0632018024017 V0632018024002 V0632017292006 V0632017117013 V0632017108003 V0632017108001 V0632017100014 V0632016197018 V0632016140020 V0632016140019 V0632016140018 V0632016140017 V0632016140016 V0632016140015 V0632016140014 V0632016140012 V0632016140011 V0632016140008 V0632016140007 V0632016140006 V0632016140004 V0632016140003 V0632016140002 V0632016140001 V0632016139020 V0632016139019 V0632016139016 V0632016139015 V0632016139014 V0632016139013 V0632016139012 V0632016139011 V0632016139009 V0632016139008 V0632016139007 V0632016139006 V0632016139005 V0632016139004 V0632016139003 V0632016139001 V0632016133019 V0632016133018 V0632016133016 V0632016133015 V0632016133011 V0632016133009 V0632016133007 V0632016133004 V0632016133003 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The agency lot list is longer than this excerpt. Read the complete list at the official source.

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

U.S. AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, and WY. O.U.S.: United Arab Emirates, Argentina, Austria, Australia, Belgium, Bahrain, Bolivia, Canada, Switzerland, China, Cyprus, Czechia, Germany, Denmark, Spain, Finland, France, United Kingdom, Greece, Guatemala, Hong Kong, Indonesia, Ireland, Israel, India, Italy, Jordan, Japan, The Republic of Korea, Kuwait, Lebanon, Luxembourg, Latvia, Mexico, The Netherlands, Norway, Panama, Peru, Philippines, Poland, Portugal, Qatar, Russian Federation, Saudi Arabia, Sweden, Singapore, Thailand, Turkey, Taiwan, Uruguay, Venezuela, and South Africa.

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
Jul 20, 2022
Recall initiation date
Jun 9, 2022
Center classification date
Jul 11, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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